Patient-reported Sleep Quality Research Articles

Which Interventions Are Effective in Treating Sleep Disturbances After THA or TKA? A Systematic Review.

Poor sleep quality is a common complaint after total joint arthroplasty (TJA), and it is associated with reports of higher pain and worse functional outcomes. Several interventions have been investigated with the intent to reduce the incidence of postoperative sleep disturbance with varying effectiveness. An aggregate of the best available evidence, along with an evaluation of the quality of those studies, is needed to provide valuable perspective to physicians and to direct future research. In this systematic review, we asked: (1) What is the reported efficacy of the most commonly studied medications and nonpharmacologic approaches, and (2) what are their side effects and reported complications? This systematic review was conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A search using a combination of controlled vocabulary and keywords was performed utilizing Medline (Ovid), Embase (Ovid), Cochrane Central, and Web of Science databases from database inception to 2023, with the last search occurring October 24, 2023, to identify studies that evaluated a sleep intervention on the effect of patient-reported sleep quality after THA or TKA. Inclusion criteria were clinical trials, comparative studies, and observational studies on adult patients who underwent primary TKA or THA for osteoarthritis and who completed validated sleep questionnaires to assess sleep quality postoperatively. We excluded studies on patients younger than 18 years, patients with sleep apnea, TKA or THA because of trauma or conditions other than osteoarthritis, revision TJA, studies in languages other than English, and studies from nonindexed journals or preprint servers. Two investigators independently screened 1535 studies for inclusion and exclusion criteria and extracted data from the included studies. Ultimately, 14 studies were included in this systematic review, including 12 randomized controlled trials and 2 prospective comparative studies. A total of 2469 participants were included, with a mean ± SD age of 65 ± 7 years and 38% men in control groups and 65 ± 7 years and 39% men in intervention groups. Sleep quality questionnaires utilized included the Pittsburgh Sleep Quality Index, Self-Rating Scale of Sleep, 100-mm VAS - Sleep, Sleep Disturbance Numeric Rating Scale, Likert scales, and one institutionally designed questionnaire. Quality analysis was performed utilizing the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Randomized Controlled Trials, where higher scores of 13 indicated a more reliable study, and the Newcastle-Ottawa Quality Assessment Scale for Cohort Studies, where higher scores of 9 indicated a more reliable study and scores < 5 represented a high risk of bias. Two of the randomized controlled trials scored a 12 of 13, and the remaining 10 met every criteria of the JBI checklist. Both comparative studies scored 5 of 9 possible points of the Newcastle-Ottawa Scale. Melatonin and selective cyclooxygenase-2 inhibitor rofecoxib were found to provide a clinically important benefit to sleep quality within the first postoperative week after TJA. However, rofecoxib was withdrawn from the market globally in 2004 over concerns about increased risk of cardiovascular events. Another cyclooxygenase-2 inhibitor, celecoxib, remains available. No other intervention demonstrated a clinical benefit. Side effects of melatonin include dizziness, headache, paresthesia, and nausea, and it is contraindicated in patients with liver failure, autoimmune conditions, or who are receiving warfarin. Long-term adverse effects of rofecoxib include hypertension, edema, and congestive heart failure, and it is contraindicated in patients with renal insufficiency or who are receiving warfarin. Melatonin is considered safe in older patients, but more caution should be taken with rofecoxib. Owing to limited evidence in support of most of the interventions we studied, none of these interventions can be recommended for routine use after TJA. Melatonin and rofecoxib may provide a benefit to sleep quality in some patients, but physicians need to understand the adverse effects and contraindications before recommending these interventions. Additionally, rofecoxib is no longer commercially available. Future investigation is warranted to evaluate the effectiveness of interventions with minimal side effect profiles for providers to be able to make an informed decision about interventions for sleep improvement after TJA. Level III, therapeutic study.

The silent threat: investigating sleep disturbances in hospitalized patients.

Sleep disruptions in the hospital setting can have adverse effects on patient safety and well-being, leading to complications like delirium and prolonged recovery. This study aimed to comprehensively assess the factors influencing sleep disturbances in hospital wards, with a comparison of the sleep quality of patients staying in single rooms to those in shared rooms. A mixed-methods approach was used to examine patient-reported sleep quality and sleep disruption factors, in conjunction with objective noise measurements, across seven inpatient wards at an acute tertiary public hospital in Sydney, Australia. The most disruptive factor to sleep in the hospital was noise, ranked as 'very disruptive' by 20% of patients, followed by acute health conditions (11%) and nursing interventions (10%). Patients in shared rooms experienced the most disturbed sleep, with 51% reporting 'poor' or 'very poor' sleep quality. In contrast, only 17% of the patients in single rooms reported the same. Notably, sound levels in shared rooms surpassed 100dB, highlighting the potential for significant sleep disturbances in shared patient accommodation settings. The results of this study provide a comprehensive overview of the sleep-related challenges faced by patients in hospital, particularly those staying in shared rooms. The insights from this study offer guidance for targeted healthcare improvements to minimize disruptions and enhance the quality of sleep for hospitalized patients.

The CCJR® Gerard A. Engh Excellence in Knee Research Award: Remote Monitoring of Sleep Disturbance Following Total Knee Arthroplasty: A Cautionary Note

BackgroundSleep disturbances are common after total knee arthroplasty (TKA). Despite the rising popularity of wearables to track sleep, little evidence exists in the arthroplasty literature regarding their efficacy. We aimed to correlate validated wearable sleep metrics with patient-reported sleep quality following TKA. MethodsPatients undergoing primary TKA were consecutively enrolled. Patients used a wearable device preoperatively and 90 days postoperatively to track five previously-validated measures of sleep. Each month, they rated their sleep quality. Wearable sleep data was correlated with patient-reported sleep quality using a point biserial correlation test. Categorical data were compared using Chi-square tests. A total of 110 patients were included. ResultsPreoperatively, 20.8% of patients reported “fairly bad” or “very bad” sleep; this increased to 44.4% 30 days postoperatively, then decreased to 26.5% 60 days postoperatively, and to 20.2% 90 days postoperatively. At 30 days postoperatively, time in bed, time asleep, and minutes of rapid eye movement sleep weakly correlated with patient-reported sleep quality (correlations 0.356, 0.345, and 0.345, respectively; P < .001). Sleep quality did not correlate with any wearable metric collected 60 or 90 days postoperatively. ConclusionsPatient-reported sleep quality following TKA initially worsened postoperatively, then improved to preoperative levels by 90 days. Time in bed, time asleep, and rapid eye movement sleep minutes only weakly correlated with patient-reported sleep quality at 30 days; no other correlations were detected. Surgeons that utilize remote monitoring following TKA should be aware that surrogate measures generated from these devices may correlate weakly, if at all, with the patient-reported outcome of the parameter being studied.

Patient-reported outcomes on sleep quality and circadian rhythm during treatment with intravenous ketamine for treatment-resistant depression.

Intravenous (IV) ketamine is a rapid acting antidepressant used primarily for treatment-resistant depression (TRD). It has been suggested that IV ketamine's rapid antidepressant effects may be partially mediated via improved sleep and changes to the circadian rhythm. This study explores IV ketamine's association with changes in patient-reported sleep quality and circadian rhythm in an adult population with TRD. Adult patients (18-64 years) with TRD scheduled for IV ketamine treatment were recruited to complete patient rated outcomes measures on sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and circadian rhythm using the Morningness-Eveningness Questionnaire (MEQ). Over a 4-week course of eight ketamine infusions, reports were obtained at baseline (T0), prior to second treatment (T1), prior to fifth treatment (T2), and 1 week after eighth treatment (T3). Forty participants with TRD (mean age = 42.8, 45% male) were enrolled. Twenty-nine (72.5%) had complete follow-up data. Paired t tests revealed statistically significant improvements at the end of treatment in sleep quality (PSQI) (p = 0.003) and depressive symptoms (Clinically Useful Depression Outcome Scale-Depression, p < 0.001) while circadian rhythm (MEQ) shifted earlier (p = 0.007). The PSQI subscale components of sleep duration (p = 0.008) and daytime dysfunction (p = 0.001) also improved. In an exploratory post hoc analysis, ketamine's impact on sleep quality was more prominent in patients with mixed features, while its chronobiotic effect was prominent in those without mixed features. IV ketamine may improve sleep quality and advance circadian rhythm in individuals with TRD. Effects may differ in individuals with mixed features of depression as compared to those without. Since this was a small uncontrolled study, future research is warranted.

Correlation Between Sleep Continuity and Patient-Reported Sleep Quality in Conscious Critically Ill Patients at High Risk of Reintubation: A Pilot Study.

It is well-established that sleep quality of ICU patients is poor, with sleep being highly fragmented by multiple awakenings. These sleep disruptions are associated with poor outcomes such as prolonged weaning duration from mechanical ventilation. Polysomnography can measure sleep continuity, a parameter associated positively with outcomes in patients treated with noninvasive ventilation, but polysomnography is not routinely available in all ICUs, and simple means to assess sleep quality are needed. The Richards-Campbell sleep questionnaire (RCSQ) assesses sleep quality in ICU patients but is difficult to administrate in patients who are not fully awake, and a simpler sleep numeric rating scale (sleep-NRS) has been proposed as an alternative. We here investigated the relationships between sleep continuity and patients-reported sleep quality. Single-center retrospective study. Medical ICU of Poitiers University Hospital. Seventy-two patients were extubated from mechanical ventilation and at high risk of reintubation. None. We analyzed 52 previously recorded polysomnographies in nonsedated and conscious ICU patients. Sleep was recorded the night after extubation. Sleep continuity was measured using an automated scoring algorithm from one electroencephalogram (EEG) channel of the polysomnography. Patient-reported sleep quality was assessed using RCSQ and sleep-NRS. Sleep continuity could be calculated on 45 polysomnographies (age: 68 [58-77], median [25th-75th]) RCSQ (62 [48-72]) and sleep-NRS (6.0 [5.0-7.0]) were obtained in 21 patients and 34 patients, respectively. Our results show a significant correlation between sleep continuity and sleep-NRS (p = 0.0037; ρ = 0.4844; n = 34) but not with RCSQ score (p = 0.6732; ρ = 0.1005; n = 20). Sleep continuity correlates with patient-reported sleep quality assessed using sleep-NRS and may capture the refreshing part of sleep. Sleep-NRS can be easily administered in ICU patients. Sleep continuity and sleep-NRS are simple tools that may prove useful to evaluate sleep quality in ICU patients.

Clinical Performance and Patient-Reported Sleep Quality Associated with Dialyzer Types: Results from the eMPORA III Trial

Clinical Performance and Patient-Reported Sleep Quality Associated with Dialyzer Types: Results from the eMPORA III Trial

Efficacy of Once-Nightly Sodium Oxybate (FT218) in Narcolepsy Type 1 and Type 2: Post Hoc Analysis From the Phase 3 REST-ON Trial.

Post hoc analyses from the phase 3 REST-ON trial evaluated efficacy of extended-release once-nightly sodium oxybate (ON-SXB; FT218) vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 (NT1) and 2 (NT2). Participants were stratified by narcolepsy type and randomized 1:1 to ON-SXB (4.5g, week 1; 6g, weeks 2-3; 7.5g, weeks 4-8; and 9g, weeks 9-13) or placebo. Assessments included mean sleep latency on Maintenance of Wakefulness Test (MWT) and Clinical Global Impression-Improvement (CGI-I) rating (coprimary endpoints) and sleep stage shifts, nocturnal arousals, and patient-reported sleep quality, refreshing nature of sleep, and Epworth Sleepiness Scale (ESS) score (secondary endpoints) separately in NT1 and NT2 subgroups. The modified intent-to-treat population comprised 190 participants (NT1, n=145; NT2, n=45). Significant improvements were demonstrated with ON-SXB vs placebo in sleep latency for NT1 (all doses, P<0.001) and NT2 (6 and 9g, P<0.05) subgroups. Greater proportions of participants in both subgroups had CGI-I ratings of much/very much improved with ON-SXB vs placebo. Sleep stage shifts and sleep quality significantly improved in both subgroups (all doses vs placebo, P<0.001). Significant improvements with all ON-SXB doses vs placebo in refreshing nature of sleep (P<0.001), nocturnal arousals (P<0.05), and ESS scores (P≤0.001) were reported for NT1 with directional improvements for NT2. Clinically meaningful improvements of a single ON-SXB bedtime dose were shown for daytime sleepiness and DNS in NT1 and NT2, with less power for the limited NT2 subgroup.

0598 Patient-Reported Sleep Quality in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate

Abstract Introduction Lower-sodium oxybate (LXB; Xywav®), which contains the same active moiety as higher-sodium oxybate (SXB; Xyrem®) but with 92% less sodium, is approved by the US Food and Drug Administration (FDA) for treating cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. LXB is recognized as clinically superior to SXB in narcolepsy by the US FDA due to lower chronic sodium exposure. Real-world data related to sleep quality following transition from SXB to LXB are lacking. Methods Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR; NCT04803786) was a patient-centric, prospective, observational, noninterventional, virtual-format study of US adults with narcolepsy (type 1 or 2) transitioning from SXB to LXB within the previous/upcoming 7 days. Longitudinal data collected during transition and for 21 weeks thereafter were based on daily and weekly questionnaires and sleep diaries instructing participants to rate the quality of their sleep and how refreshed they felt upon waking, and to record their sleep latency, wake after sleep onset (WASO), time in bed (TIB), and total sleep time (TST). Results The mean (standard deviation [SD]) age of the 85 participants (narcolepsy type 1, n=45; narcolepsy type 2, n=40) was 40.3 (13.0) years; most were female (73%) and White (87%). Almost all participants took SXB (82/85, 96%) twice nightly prior to transition and LXB (82/84, 98%) twice nightly after transition. Most participants rated their sleep quality as “good” or “very good” at baseline (45/84, 54%) and end of study (38/71, 54%), while 24/84 (29%) and 30/71 (42%) reported feeling “well-rested” or “very well-rested” at baseline and end of study, respectively. At end of study, changes (n=71) in mean (SD) sleep latency, WASO, TIB, and TST were −10.5 (16.2), −14.8 (56.6), 7.6 (67.7), and 33.0 (93.8) minutes, respectively. Conclusion Although participant-reported sleep quality was generally unchanged during the study, a greater percentage of participants reported feeling refreshed at end of study (on LXB) than at baseline (on SXB); however, there was no non-transitioning arm for comparison. Small changes were noted at end of study in sleep parameters, including sleep latency, WASO, and TST. Support (if any) Jazz Pharmaceuticals

Sleep quality associated with neuroimaging measures of CSF flow in individuals with Parkinson’s disease (N5.001)

<h3>Objective:</h3> To investigate the relationship between sleep quality and cerebrospinal fluid (CSF) flow in individuals with Parkinson’s disease (PD). <h3>Background:</h3> Previous studies have emphasized the role of CSF circulation in the clearance of brain waste products, with recent findings demonstrating increased CSF flow during sleep. CSF circulation impairment could play a major role in neurodegenerative proteinopathies such as PD, a commonly encountered feature of which is disrupted sleep. Here, we assessed the relationship between patient-reported sleep quality and imaging assays of CSF flow. <h3>Design/Methods:</h3> Imaging and clinical assessments were completed in 23 PD participants aged 56 to 79 (M_age=66.70; 16 males). The Montreal Cognitive Assessment (MoCA) and Unified Parkinson’s Disease Rating Scale (UPDRS) were administered; subjective sleep measurements were recorded using the Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) items from the Patient-Reported Outcomes Measurement Information System (PROMIS) scale. MRI phase contrast sequences quantified CSF flux (mL/min) via the cerebral aqueduct. Net CSF flow was defined as the difference between caudal and cranial flow, whereas absolute flow was calculated as the sum of total caudal and cranial flow per cardiac cycle. <h3>Results:</h3> Participants had mean MoCA scores of 24.17 (range 13–30) and UPDRS scores of 30.70 (7–59). PROMIS scores for SD and SRI were 20.14 (9–32) and 15.00 (8–24), respectively. Mean CSF measurements were 0.25 mL/min (−0.29–0.88) for net and 8.11 mL/min (3.55–16.34) for absolute flow. Higher SRI scores correlated with greater net CSF flow while awake (r=0.531, p=0.023). Additionally, SRI and age explained 73.4% of variation in absolute CSF flow in a linear regression model (F(3,15)=24.5, p&lt;0.0001). <h3>Conclusions:</h3> Self-reported sleep impairment is associated with increased CSF flow in awake individuals with PD. This study is the first to link patient-reported measures of sleep with alterations to CSF flow. These data support novel outcomes for clinical studies that improve sleep. <b>Disclosure:</b> Mr. Ponzo has nothing to disclose. Dr. Hett has nothing to disclose. Mr. Eisma has nothing to disclose. Mr. Elenberger has nothing to disclose. Mr. Song has nothing to disclose. An immediate family member of Dr. McKnight has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Deciphera. The institution of Dr. McKnight has received research support from RSNA. Dr. Considine has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MDisrupt. Dr. Considine has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Park Dietz &amp; Associates. The institution of Dr. Considine has received research support from NIH. The institution of Dr. Considine has received research support from DoD. The institution of Dr. Considine has received research support from Acadia Pharmaceuticals. Manus Donahue, 13717 has received personal compensation for serving as an employee of Alterity. Manus Donahue, 13717 has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alterity. Manus Donahue, 13717 has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Manus Donahue, 13717 has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Global Blood Therapeutics. Manus Donahue, 13717 has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. The institution of Manus Donahue, 13717 has received research support from National Institutes of Health. Dr. Claassen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Neuroscience. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spark . The institution of Dr. Claassen has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Alterity. Dr. Claassen has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva Neuroscience. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for HD Insights. The institution of Dr. Claassen has received research support from NIH. The institution of Dr. Claassen has received research support from CHDI. The institution of Dr. Claassen has received research support from HDSA. The institution of Dr. Claassen has received research support from Department of Defense. The institution of Dr. Claassen has received research support from Griffin Family Foundation. The institution of Dr. Claassen has received research support from Neurocrine. The institution of Dr. Claassen has received research support from Vaccinex. The institution of Dr. Claassen has received research support from AbbVie. The institution of Dr. Claassen has received research support from CHDI. The institution of Dr. Claassen has received research support from Genentech/ Roche. The institution of Dr. Claassen has received research support from Prilenia. The institution of Dr. Claassen has received research support from Neurocrine/ HSG.

The Herbal Medicine Suanzaoren (Ziziphi Spinosae Semen) for Sleep Quality Improvements: A Systematic Review and Meta-analysis.

Sleep disturbances are common and bothersome among cancer and noncancer populations. Suanzaoren (Ziziphi Spinosae Semen) is commonly used to improve sleep, yet its efficacy and safety are unclear. We systematically searched PubMed, Cochrane Library, and EMBASE from inception through October 5, 2021, to identify randomized trials of Suanzaoren. We included randomized trials comparing Suanzaoren to placebo, medications, cognitive behavioral therapy (CBT), or usual care for improving sleep outcomes in cancer and noncancer patients with insomnia or sleep disturbance. We performed a risk of bias analysis following Cochrane guidelines. Depending on heterogeneity, we pooled studies with similar comparators using fixed- and random-effects models. We included participants with insomnia disorder (N = 785) or sleep disturbance (N = 120) from 9 trials. Compared with placebo, Suanzaoren led to significant subjective sleep quality improvements in participants with insomnia and patients with sleep disturbance combined (standard mean difference -0.58, 95% CI -1.04, -0.11; P < .01); Compared with benzodiazepines or CBT, Suanzaoren was associated with a significant decrease in insomnia severity (mean difference -2.68 points, 95% CI -5.50, -0.22; P = .03) at 4 weeks in the general population and cancer patients. The long-term effects of Suanzaoren were mixed among trials. Suanzaoren did not increase the incidence of major adverse events. The placebo-controlled studies had a low risk of bias. Suanzaoren is associated with short-term patient-reported sleep quality improvements among individuals with insomnia or sleep disturbance. Due to the small sample size and variable study quality, the clinical benefits and harms of Suanzaoren, particularly in the long term, should be further assessed in a sufficiently powered randomized trial. PROSPERO CRD42021281943.

Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer—a double-blind, randomized placebo-controlled clinical multicenter phase IV trial

PurposeInsomnia is frequent in patients with advanced cancer, and a variety of pharmacological agents is used to treat this condition. Still, few clinical trials have investigated the effectiveness of pharmacological sleep therapies in this patient group. We aimed to study the short-term effectiveness of zopiclone on sleep quality in patients with advanced cancer who report insomnia.MethodsA randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase IV clinical trial in adult patients with metastatic malignant disease and insomnia. Patients were treated with zopiclone or placebo for six subsequent nights. Primary end point was patient-reported sleep quality during the final study night (NRS 0–10). Secondary end points were patient-reported sleep onset latency (SOL) and total sleep time (TST).ResultsForty-one patients were randomized, with 18 being analyzed in the zopiclone group and 21 in the placebo group. Median age was 66, median Karnofsky performance score was 80, and 56% were male. Mean sleep quality at end of study was 2.9 (CI 2.3 to 3.8) in the zopiclone group and 4.5 (CI 3.6 to 5.4) in the placebo group (p = 0.021). At end of study, SOL was significantly different between the treatment groups: zopiclone 29 min (CI 13 to 51) and placebo 62 min (CI 40 to 87) (p = 0.045). TST was not significantly different across groups: zopiclone 449 min (403 to 496) and placebo 411 min (CI 380 to 440) (p = 0.167).ConclusionZopiclone improved short-term patient-reported sleep quality in this cohort of patients with advanced cancer.Trial registrationClinicalTrials.gov Identifier: NCT02807922.

JS09.5.A Is Radiation Dose to Sleep-relevant Brain Structures Associated with Lower Sleep Quality in Adults with Primary Brain Tumors?

Abstract Background Sleep plays a central role in optimal brain health and daily functioning, and poor sleep is associated with impaired cognitive functioning and reduced quality of life. Despite improved precision of modern radiotherapy (RT) for brain tumors, radiation to healthy tissue, including brain structures relevant for sleep/wake regulation, is often inevitable. In the present study, we investigate whether radiation dose to sleep/wake-relevant brain structures is associated with poorer patient-reported sleep quality in primary brain tumor patients. Material and Methods Patients who had received RT for non-glioblastoma primary brain tumors between 2006 and 2016 were included. They completed the Pittsburg Sleep Quality Index (PSQI) and mean radiation doses to sleep/wake-relevant structures (i.e., brainstem, thalamus, hypothalamus, and the pituitary and pineal glands) were calculated based on planning CTs and contrast-enhanced MR-images. Mean radiation dose (Dmean) to brain structures were compared between patients with and without impaired sleep outcomes using bootstrapped independent t-tests. Differences with effect sizes (ES, Cohen’s d) exceeding ± 0.3 are reported. Results A total of 78 patients (glioma, grade 1-3 = 28; meningioma = 22, pituitary = 16, other = 12) were included. Median time since RT was 4.6 years (range = 8.4 years). Mean global PSQI score was 5.13 (SD = 3.1). No differences were observed between tumor types, F (3,74) = 0.37, η 2= .02. Clinical sleep disturbance (PSQI &amp;gt; 5) was reported by 37.2% (n=29). Compared with patients without sleep disturbance, those with sleep disturbance had received a higher radiation dose to the pituitary gland, Dmean = 26.11 Gy, SE = 2.59, versus 34.57 Gy, SE = 3.43, ES(d) = - 0.46, 95% CI [-0.93, 0.003]. Furthermore, compared with patients reporting normal sleep latency (SL), those with poor SL had received a higher radiation dose to the pituitary gland, Dmean = 24.55 Gy, SE = 3.71, versus 32.60 Gy, SE = 2.48, ES(d) = - 0.44, 95% CI [-0.90, 0.03], and the brain stem, Dmean = 15.32 Gy, SE = 2.71, versus 20.20 Gy, SE = 2.01, ES(d) = -3.44, 95% CI [-0.80, 0.12]. Finally, compared with patients with a high sleep efficiency (&amp;gt;85%), those with a low sleep efficiency had received a higher radiation dose to the thalamus, Dmean = 18.11 Gy, SE = 2.36, versus 24.55 Gy, SE = 4.43, ES(d) = -0.35, 95% CI [-0.83, 0.15], and the pineal gland, Dmean = 16.20 Gy, SE = 2.48, versus 23.10 Gy, SE = 4.25, ES(d) = -0.36, 95% CI [-0.85, 0.13]. Conclusion The prevalence of clinical sleep disturbances in patients with primary brain tumors was high (37%). Our results indicated that higher radiation doses to the pituitary gland, brain stem, thalamus, and pineal gland may be risk factors for poor sleep quality in patients with a primary brain tumor.

Improved Sleep Quality Is Associated with Reduced Insulin Resistance in Cancer Survivors Undertaking Circuit, Interval-Based Exercise.

Cancer patients often experience poor sleep quality, typically induced by cancer-related treatments, a sedentary lifestyle, and psychological distress, leading to an increased risk of metabolic dysregulation such as obesity and insulin resistance. In this novel 16-week pilot study, we examined the effect of a circuit-based aerobic and resistance exercise intervention on self-reported sleep quality in breast, prostate, and colorectal cancer survivors and explored the association between changes in sleep quality and insulin resistance. Survivors of breast, prostate or colorectal cancers who were sedentary, overweight or obese (BMI>25.0 kg/m2) were randomized to exercise (n=60) or usual care (n=30). The 16-week intervention included supervised moderate-vigorous aerobic (65-85% of VO2max) and resistance (65-85% of 1-repetition maximum) exercise performed in a circuit, interval fashion three times per week. Patient-reported sleep quality and insulin resistance were assessed at baseline and post-intervention using Pittsburgh Sleep Quality Index (PSQI) and Homeostasis Model of Assessment (HOMA-IR), respectively. Mean changes in PSQI score that are negative demonstrate improvements in sleep. Between-group differences were determined using repeated-measures analysis of variance. Associations between changes in PSQI and insulin resistance were computed using Pearson correlations. Participants were 63.2±10.8 years old, obese (87%), female (55%), and completed chemotherapy + radiation therapy (75%). Adherence to the intervention was 92% and the retention rate was 100%. Post-intervention, the PSQI global score improved significantly in the exercise group when compared to usual care (mean between-group difference, -2.7; 95% CI, -4.2 to -0.6). Change in PSQI was inversely associated with change in HOMA-IR (r=-0.91; p<0.01) among the exercise group. A circuit, interval-based aerobic and resistance exercise intervention improved patient-reported sleep quality in breast, prostate, and colorectal cancer survivors. Additionally, this exercise-induced improvement in sleep-quality may result in reduced insulin resistance.

0401 Efficacy of Once-Nightly Sodium Oxybate (ON-SXB; FT218) By Narcolepsy Type: Post-hoc Analyses From the REST-ON Trial

Abstract Introduction Once-nightly sodium oxybate (ON-SXB; FT218) was evaluated for treatment of narcolepsy in the phase 3 REST-ON trial (NCT02720744). Significant improvement was shown for the three coprimary endpoints mean sleep latency on the Maintenance of Wakefulness test (MWT), Clinical Global Impression of Improvement (CGI-I) rating, and weekly number of cataplexy attacks overall (all P&amp;lt;0.001 vs placebo) and in post-hoc analyses by narcolepsy type (NT1/NT2) for MWT and CGI-I (all P&amp;lt;0.05). Post-hoc efficacy analyses of objective and subjective measures of disrupted nighttime sleep and daytime sleepiness by narcolepsy type were conducted. Methods Participants aged ≥16 years were randomized 1:1 to receive ON-SXB (1 week, 4.5 g; 2 weeks, 6 g; 5 weeks, 7.5 g; 5 weeks, 9 g) or placebo. Mixed-effects models for repeated measures were used to calculate P values for change from baseline vs placebo at weeks 3 (6 g), 8 (7.5 g), and 13 (9 g) for secondary REST-ON endpoints of Epworth sleepiness scale (ESS) score, sleep shifts (ie, the number of shifts from stages N1, N2, N3 and rapid eye movement [REM] sleep to Wake and from N2, N3 and REM sleep to N1), nocturnal arousals (NA), and patient-reported sleep quality and refreshing nature of sleep (100-point visual analog scale). Results Of 190 participants, 145 had NT1 (ON-SXB, n=73; placebo, n=72) and 45 had NT2 (ON-SXB, n=24; placebo, n=21). Improvements with ON-SXB vs placebo were reported for shifts to a lighter stage of sleep (NT1: 6, 7.5, 9 g, all P&amp;lt;0.001; NT2: 6 and 7.5 g, P&amp;lt;0.05; 9 g, P&amp;lt;0.001), NA (NT1: 6 g, P&amp;lt;0.05; 7.5 and 9 g, P&amp;lt;0.01; NT2: 6 g, directional improvement; 7.5 and 9 g, P&amp;lt;0.05), and sleep quality (NT1: 6, 7.5, 9 g, all P&amp;lt;0.001; NT2: 6, 7.5, 9 g, all P&amp;lt;0.05). Significant improvements in ESS and refreshing nature of sleep for ON-SXB vs placebo were reported for NT1 (6, 7.5, 9 g, P≤0.001) with directional improvements observed for the NT2 subgroup. Conclusion Results of these subgroup efficacy analyses are generally consistent with previously reported REST-ON endpoints and support ON-SXB treatment efficacy in adults with NT1 or NT2. Support (If Any) Avadel Pharmaceuticals

Sleep increases leaks and asynchronies during home noninvasive ventilation: a polysomnographic study.

In patients treated with noninvasive ventilation, sleep-related breathing changes can modify patient-ventilator interactions, which could reduce its effectiveness. The aim of this prospective observational study was to determine the impact of sleep/wake state on leaks, upper airway obstructive events, and asynchronies in patients treated by long-term noninvasive ventilation. Stable patients adapted to noninvasive ventilation were considered for nocturnal polysomnography. Unintentional leaks, upper airway obstructive events, and asynchronies were compared between sleep and awake periods. Twenty-eight patients were enrolled. Underlying diagnoses were neuromuscular disease (n = 11), chest wall disease (n = 8), and obesity-hypoventilation (n = 9). Leaks were more frequent in sleep than in awake periods, with a median of 10% (interquartile range [IQR], 0%-75%) vs 1% (IQR, 0%-9%) of time (P < .001), respectively. During sleep, asynchronies with and without associated leak affected 27% of breaths (IQR, 16%-39%) compared with non-leak-related asynchronies that were recorded in 8% (IQR, 3%-25%) of breaths (P < .001). Asynchronies affecting more than 10% of total breaths were more frequent in sleep (25 patients, 89%) than in awake time (8 patients, 29%; P = .25). Eleven patients (39%) presented with 5 or more upper airway obstructive events without reduction in ventilatory drive per hour of sleep. In patients adapted to home noninvasive ventilation, leaks, asynchronies, and upper airway obstructive events are frequent during the night and are concentrated in sleep periods. Asynchronies are often associated with leaks. These findings may have clinical implications considering that in patients with low sleep efficiency respiratory events could be underestimated if sleep is not evaluated. Martí S, Ferré A, Sampol G, etal. Sleep increases leaks and asynchronies during home noninvasive ventilation: a polysomnographic study. J Clin Sleep Med. 2022;18(1):225-233.

Patient-Reported Sleep Quality at Baseline Correlates with 1-Year Survival after Allogeneic Hematopoietic Cell Transplantation in Adults

Background: While allogeneic hematopoietic cell transplantation (alloHCT) offers a potential cure to many patients with serious blood disorders, the process remains physically and psychologically arduous. Sleep dysfunction is nearly universal in the early post-HCT period and can lead to impaired quality of life, depression, fatigue and inflammation. Sleep dysfunction may adversely impact alloHCT outcomes through increased pro-inflammatory pathways as shown to be associated in other populations, and lead to adverse post-alloHCT outcomes. We hypothesized that patient-reported sleep dysfunction at baseline would correlate with post-alloHCT outcomes.Material and Methods: From 2011 to 2013, the Center for International Blood and Marrow Transplant Research prospectively enrolled 390 patients from 7 transplant centers to assess the feasibility of collecting patient-reported outcomes. Patients completed the SF-36 and FACT-BMT surveys at pre-HCT, day 100, 6 months and 1 year. Sociodemographic information, disease- and transplant-specific data were routinely collected. In this study, we focus on responses to the sleep-specific question from FACT-BMT in a subset of adult patients (n=198) who underwent alloHCT for acute leukemia, myelodysplastic syndrome and myeloproliferative neoplasms. Descriptive statistics were used to summarize the patient sample and survival analysis was conducted using the Kaplan-Meier estimator. A significance level of 0.05 was used, and all tests are two-sided. The sleep question in FACT-BMT is a single validated question “I am sleeping well” with 5 answers (0- not at all, 1- a little bit, 2- somewhat, 3- quite a bit, 4- very much). We analyzed 0/1/2 as “poor sleep” and 3/4 as “good sleep” groups.Results: Table 1 shows the baseline characteristics of the cohort. Patients aged <55 years, Karnofsky Performance Score (KPS) <90, and annual household income < $60,000 were more likely to have baseline poor sleep. Median follow-up of survivors was similar between the two groups and all survivors (N=131) had at least 12 months of follow up. The 1-year overall survival was 66 (59-73)%. Baseline “good sleep” in patients <55 years correlated with superior survival at 100 days, 6 months and 1 year compared to “poor sleep” <55 years (p<0.001) (Table 2). Baseline sleep did not correlate with survival in the ≥55 age group in unadjusted analysis (Figure).Conclusions: Nearly 46% of adults undergoing alloHCT have self-reported poor sleep at pre-transplant baseline. Baseline sleep correlated with 1-year survival in patients under 55 years but not in those over 55 years of age. These intriguing results suggest further research to study potential etiologies of pre-transplant sleep dysfunction, especially in relation to pro-inflammatory pathways. Given the prevalence of sleep dysfunction, interventions to improve sleep should also be tested. [Display omitted] DisclosuresD'Souza:Merck: Research Funding; Prothena: Research Funding; Celgene: Consultancy. Lee:Bristol-Myers-Squibb: Other: One-time advisory board member; Amgen: Other: One-time advisory board member; Mallinckrodt: Honoraria; Kadmon: Other: One-time advisory board member.

Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis.

Poor sleep quality affects nearly one-third of breast cancer survivors and is associated with insulin resistance. The purpose of this secondary analysis was to examine the effects of a 16-week exercise intervention on patient-reported sleep quality among breast cancer survivors and assess whether changes in patient-reported sleep quality were associated with cardiometabolic biomarkers. We explored Hispanic ethnicity as a moderator of the effects of exercise on patient-reported sleep quality. Breast cancer survivors who were overweight or obese were randomized to exercise (n = 50) or usual care (n = 50). The 16-week intervention included aerobic and resistance exercise. Patient-reported sleep quality (Pittsburgh Sleep Quality Index [PSQI]) and biomarkers of cardiometabolic health were assessed at baseline and post-intervention. Within- and between-group differences were assessed using general linear models repeated-measures analyses of variance and mixed-model repeated-measure analysis, respectively. Associations between changes in PSQI and cardiometabolic biomarkers were computed using Pearson correlations. Linear mixed-models were used to evaluate effect modification by ethnicity. Participants were 52 ± 10.4 years old, and over half were of Hispanic ethnicity. As compared to usual care, PSQI global scores improved significantly in the exercise group (mean between-group difference -2.2; 95% CI -3.2 to -0.6). Change in PSQI was inversely associated with changes in all cardiometabolic biomarkers (p < 0.01) among the exercise group. Ethnicity was found to moderate the effects of exercise training on global sleep quality (p < 0.001). An aerobic and resistance exercise intervention effectively improved patient-reported sleep quality in breast cancer survivors. Hispanic ethnicity as a moderator showed greater improvement in patient-reported sleep indicating Hispanic versus non-Hispanic breast cancer survivors may derive larger sleep benefits. NCT01140282.

Objective sleep measures after endoscopic sinus surgery in patients with chronic rhinosinusitis.

Poor sleep quality is common in chronic rhinosinusitis (CRS). Prior studies have demonstrated improvements in patient-reported measures of sleep quality following endoscopic sinus surgery (ESS). The purpose of this study was to evaluate the effect of ESS on objective sleep parameters and identify any associations between specific objective measures and patient characteristics, comorbidities, and patient-reported outcome measures (PROMs). Adults with CRS undergoing ESS were prospectively enrolled from 4 centers across North America. Any subject previously diagnosed with a known primary sleep disorder was excluded. Objective sleep indices were recorded using a portable sleep diagnostic device preoperatively and postoperatively. Patient-reported outcome instruments were completed including the Pittsburgh Sleep Quality Index (PSQI) and the 22-item Sino-Nasal Outcome Test (SNOT-22). Thirty-six patients (mean age 47 years, 56% male) completed baseline and postoperative sleep studies with mean ± standard deviation (SD) follow-up 9.6 ± 7.7 months. Mean PSQI and SNOT-22 before and after ESS was 10.2 ± 3.9 vs 7.8 ± 4.4 (p = 0.001); and 54.6 ± 14.6 vs 28.5 ± 15.3 (p < 0.001), respectively. Total sleep time, sleep latency, and awakenings after sleep onset did not change following ESS (all p > 0.5) despite improvements in PSQI and SNOT-22. Changes in PSQI did not correlate with comorbidities or objective sleep indices (all p > 0.1). In this multicenter prospective cohort, objective sleep indices were not improved following ESS for CRS despite significant improvements in patient-reported sleep quality and CRS-specific QOL.

Is there an association between subjective sleep quality and daily delirium occurrence in critically ill adults? A post hoc analysis of a randomised controlled trial

ObjectivesWhether and how delirium and sleep quality in the intensive care unit (ICU) are linked remains unclear. A recent randomised trial reported nocturnal low-dose dexmedetomidine (DEX) significantly reduces incident ICU...

0780 Effect Of A Sleep/Circadian Friendly Protocol On The Outcomes Of Patients Admitted To The Medical Intensive Care Unit: A Randomized Control Trial

Abstract Introduction Critically ill patients often suffer from fragmented sleep due to light and noise in the intensive care unit (ICU). We investigated whether placing patients in a sleep/circadian friendly protocol improved patient-reported sleep quality and ICU outcomes. Methods Patients were included if they were expected to have a &amp;gt;24-hour stay. Exclusion criteria included age &amp;lt;18 years, pregnancy, frequent overnight assessments, poor prognosis, pre-existing cognitive impairment, and severe psychological disorders. Patients were randomized to a sleep/circadian protocol or control protocol. Demographic, treatment, sound (dB), light (lux), patient-reported sleep, and medical outcomes were collected. Those who were not maintained in the sleep/circadian protocol were combined with the controls for statistical analysis. Univariate analysis was performed with Chi-Square test and Wilcoxon rank-sum test. Results Sixty-one patients were enrolled: 28 randomized to sleep/circadian protocol, 33 to control protocol. 14 subjects were excluded from analysis due to developing criteria for exclusion. Nine patients (median age 50 years, 6 females) maintained in the sleep/circadian protocol, 13 patients were not maintained in sleep/circadian protocol and 25 patients in control protocol (median age 64 years, 20 females). There was no difference in age, gender, or race between groups (p&amp;gt; 0.05). Median ICU first overnight dB level (10:00pm-6:00am) was 44.2 (±2.7) for sleep/circadian protocol and 50.5 (±4.9) for combined group (p= 0.008). Median ICU first overnight lux (10:00pm-4:00am) was 2.28 (±61.3) in sleep/circadian protocol and 18.42 (±90.9) in combined group (p=0.0374). A continued stay in the sleep/circadian protocol resulted in decreased total decibel level (p= 0.0018) decreased total overnight lux exposure (p= 0.0025) and decreased reported awakenings in first night (p= 0.0175). There were no differences in ICU length of stay, inpatient mortality, or readmission rates between groups (p&amp;gt;0.05). Three patients developed delirium, all originally randomized to control group. Conclusion We report on the successful outcomes associated with a sleep/circadian friendly protocol within a large tertiary center medical ICU which resulted in significant decreases in objectively assessed noise and light, and subjectively reported nocturnal awakenings. We continue to collect data to determine if the sleep/circadian friendly protocol should be permanently implemented in the ICU. Support None.