Leeds Sleep Evaluation Questionnaire Research Articles

Low-Dose Morphine Does Not Cause Sleepiness in COPD: A Secondary Analysis of a Randomized Trial.

Regular, low-dose, sustained-release morphine is frequently prescribed for persistent breathlessness in chronic obstructive pulmonary disease (COPD). However, effects on daytime sleepiness, perceived sleep quality and daytime function have not been rigorously investigated. Determine the effects of regular, low-dose, sustained-release morphine on sleep parameters in COPD. Pre-specified secondary analyses of validated sleep questionnaire data from a randomized trial of daily, low-dose, sustained -release morphine versus placebo over four weeks commencing at 8mg or 16mg/day with blinded up-titration over two weeks to a maximum of 32mg/day. Primary outcomes for these analyses were week-1 Epworth Sleepiness Scale (ESS) and Karolinska Sleepiness Scale (KSS) responses on morphine versus placebo. Secondary outcomes included Leeds Sleep Evaluation Questionnaire (LSEQ) scores (end of weeks 1 and 4), KSS and ESS beyond week-1 and associations between breathlessness, morphine, and questionnaire scores. 156 people were randomized. Week-1 sleepiness scores were not different on morphine versus placebo (∆ESS [95%CI] versus placebo: 8mg group: -0.59 [-1.99, 0.81], p=0.41; 16mg group: -0.72 [-2.33, 0.9], p=0.38; ∆KSS versus placebo: 8mg group: 0.11 [-0.7, 0.9], p=0.78; 16mg group: -0.41 [-1.31, 0.49], p=0.37). This neutral effect persisted at later timepoints. In addition, participants who reported reduced breathlessness with morphine at 4 weeks also had improvement in LSEQ domain scores including perceived sleep quality and daytime function. Regular, low-dose morphine does not worsen sleepiness when used for breathlessness in COPD. Individual improvements in breathlessness with morphine may be related to improvements in sleep.

Chronic and postprandial effect of blueberries on cognitive function, alertness, and mood in participants with metabolic syndrome – results from a six-month, double-blind, randomized controlled trial

BackgroundAnthocyanin and blueberry intakes positively associated with cognitive function in population-based studies and cognitive benefits in randomized controlled trials of adults with self-perceived or clinical cognitive dysfunction. To date, adults with metabolic syndrome (MetS) but without cognitive dysfunction are understudied. ObjectivesCognitive function, mood, alertness, and sleep quality were assessed as secondary end points in MetS participants, postprandially (>24 h) and following 6-mo blueberry intake. MethodsA double-blind, randomized controlled trial was conducted, assessing the primary effect of consuming freeze-dried blueberry powder, compared against an isocaloric placebo, on cardiometabolic health >6 mo and a 24 h postprandial period (at baseline). In this secondary analysis of the main study, data from those completing mood, alertness, cognition, and sleep assessments are presented (i.e., n = 115 in the 6 mo study, n = 33 in the postprandial study), using the following: 1) Bond-Lader self-rated scores, 2) electronic cognitive battery (i.e., testing attention, working memory, episodic memory, speed of memory retrieval, executive function, and picture recognition), and 3) the Leeds Sleep Evaluation Questionnaire. Urinary and serum anthocyanin metabolites were quantified, and apolipoprotein E genotype status was determined. ResultsPostprandial self-rated calmness significantly improved after 1 cup of blueberries (P = 0.01; q = 0.04; with an 11.6% improvement compared with baseline between 0 and 24 h for the 1 cup group), but all other mood, sleep, and cognitive function parameters were unaffected after postprandial and 6-mo blueberries. Across the ½ and 1 cup groups, microbial metabolites of anthocyanins and chlorogenic acid (i.e., hydroxycinnamic acids, benzoic acids, phenylalanine derivatives, and hippuric acids) and catechin were associated with favorable chronic and postprandial memory, attention, executive function, and calmness. ConclusionsAlthough self-rated calmness improved postprandially, and significant cognition-metabolite associations were identified, our data did not support strong cognitive, mood, alertness, or sleep quality improvements in MetS participants after blueberry intervention.This trial was registered at clinicaltrials.gov as NCT02035592.

Intranasal dexmedetomidine improves postoperative sleep quality in older patients with chronic insomnia: a randomized double-blind controlled trial.

Objective: This study was determined to investigate the impact of intranasal dexmedetomidine (DEX) on postoperative sleep quality in older patients (age over 65) with chronic insomnia during their hospitalization after surgery. Design: A randomized double-blind controlled trial was conducted to compare the effects of intranasal dexmedetomidine spray with a placebo group. Setting and Participants: The study was carried out at Xiangya Hospital, Central South University. 110 participants with chronic insomnia were analyzed. Methods: This trial enrolled older patients who underwent total hip/knee arthroplasty and randomized them to receive intranasal dexmedetomidine (2.0μg/kg) or saline daily at around 9 p.m. after surgery until discharge. The primary outcomes were subjective sleep quality assessed with the Leeds Sleep Evaluation Questionnaire (LSEQ). The secondary outcomes included the objective sleep quality measured with the Acti-graph, the Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI). The other outcomes included the incidence of delirium, levels of inflammatory factors, visual analog scale (VAS) pain scores, postoperative opioid consumption, and treatment-related adverse events. Results: 174 patients were screened for eligibility, and 110 were recruited and analyzed. The DEX group had significantly higher scores on both the LSEQ-Getting to sleep and LSEQ-Quality of Sleep at each time point compared to the placebo (p < 0.0001), The least squares (LS) mean difference in LSEQ-GTS score at T0 between placebo group and DEX group was 2 (95% CI, -1-6), p = 0.4071 and at T5 was -14 (95% CI, -17 to -10), p < 0.0001; The LS mean difference in the LSEQ-QOS score at T0 was -1 (95% CI, -4 to 1), p = 0.4821 and at T5 was -16 (95% CI, -21 to -10), p < 0.0001. The DEX group exhibited significant improvement in Total Sleep Time (TST), Sleep Onset Latency (SOL), and Sleep Efficiency (SE), at each time point after treatment compared to the placebo group (p < 0.0001). The PSQI and ISI scores in the DEX group were reduced after treatment (p < 0.001). No significant adverse events were reported with the use of dexmedetomidine. Conclusion and Implications: This study demonstrates that intranasal administration of dexmedetomidine improves postoperative sleep quality in older patients with chronic insomnia who undergo surgery, without increasing the incidence of adverse effects. Clinical Trial Registration: http://www.chictr.org.cn/, identifier ChiCTR2200057133.

A Case Report on Peripheral Facial Nerve Palsy and Sleep Disorders After Microvascular Decompression

Objectives: This study reports on the efficacy of Korean medicine treatments for peripheral facial nerve palsy and sleep disorders that occur after microvascular decompression.Methods: A 57-year-old female patient with right facial palsy was treated with herbal medicines and acupuncture for 36 days. The treatment effect was evaluated using the House Brackmann Grading System (HBGS), Yanagihara’s Unweighed Grading System (Yanagihara’s score), and the Korean Modified Leeds Sleep Evaluation Questionnaire (KMLSEQ).Results: Following treatment, the patient showed a decrease in HBGS and an improvement in Yanagihara’s score and KMLSEQ score.Conclusions: Korean medicine treatments appeared to be effective in reducing facial nerve palsy. Further clinical research on patients with facial nerve palsy is needed.

Effects of aromatherapy on sore throat, nasal symptoms and sleep quality in adults infected with COVID-19: A randomized controlled trial

BackgroundPatients with coronavirus disease 2019 (COVID-19) usually complain of fever, cough, and sore throat. This study examined the effects of aromatherapy on sore throat, nasal symptoms, stress, fatigue, and sleep quality by administering it to adults with post-COVID-19 condition. MethodsThis study was conducted in a randomised controlled design. Its target population were adults who were released from COVID-19 quarantine treatment within 45 days from infection onset and capable of performing daily activities after isolation treatment. The participants were randomised into aromatherapy group (AG) and control group (CG). To test experimental treatment effects, the levels of sore throat, nasal symptoms, stress, fatigue and sleep quality were measured at the baseline (pre-test) and after the trial (post-test), using the numerical rating scale for sore throat, stress and fatigue, the Total Nasal Symptoms Score for nasal symptoms, and the Korean Version of Modified Leeds Sleep Evaluation Questionnaire for quality of sleep. ResultsAfter experimental treatment, there was a significant difference in sore throat in AG compared to CG on the 3rd day (t=-2.022 p=0.048) and 4th day (t=-2.450, p=0.017) of treatment. There was also a significant difference in fatigue between AG and CG on the 2nd day(t=-2.748, p=0.008), 3rd day (t=-2.948, p=0.005) and 4th day (t=-3.084, p=0.003) of treatment. There was no significant difference in TNSS, stress, and sleep quality between the two groups after the experimental treatment. ConclusionInhaling aroma essential oils reduced sore throat and fatigue in adults with post-COVID-19 condition, demonstrating the feasibility of aromatherapy as an effective treatment. Trial registrationThe study was registered with Clinical Research Information Service (KCT0008029).

Effects of bilateral erector spinae plane block for posterior lumbar spine surgery in elderly patients.

With the rapid development of aging population, the number of elderly patients undergoing posterior lumbar spine surgery continues to increase. Lumbar spine surgery could cause moderate to severe postoperative pain, and the conventional opioid-based analgesia techniques have many side effects, which are barriers to the recovery after surgery of the elderly. Previous studies have demonstrated that erector spinae plane block (ESPB) could bring about favorable analgesia in spinal surgery. As far as the elderly are concerned, the analgesic and recovery effects of ESPB on posterior lumbar spine surgery are not completely clear. This study aims to observe the effects of bilateral ESPB on elderly patients undergoing posterior lumbar spine surgery, and to improve the anesthesia techniques. A total of 70 elderly patients of both sex, who were selected from May 2020 to November 2021, scheduled for elective posterior lumbar spine surgery, and in the age of 60-79 years, with American Society of Anesthesiologists class Ⅱ-Ⅲ, were divided into a ESPB group and a control (C) group using a random number table method, with 35 patients each. Before general anesthesia induction, 20 mL 0.4% ropivacaine was injected to the transverse process of L3 or L4 bilaterally in the ESPB group and only saline in the C group. The score of Numerical Rating Scale (NRS) indicating pain at rest and on movement within 48 h after operation, time of first patient control analgesia (PCA), cumulative consumptions of sufentanil within 48 hours, Leeds Sleep Evaluation Questionnaire (LSEQ) scores on the morning of day 1 and day 2 after operation, Quality of Recovery-15 (QoR-15) scores at 24 and 48 h after operation, full diet intake times, perioperative adverse reactions such as intraoperative hypotension, postoperative dizziness, nausea, vomiting, and constipation were compared between the 2 groups. A total of 70 patients were enrolled and 62 subjects completed the study, including 32 in the ESPB group and 30 in the C group. Compared with the C group, the postoperative NRS scores at rest at 2, 4, 6, and 12 h and on movementat at 2, 4, and 6 h were lower, time of first PCA was later, sufentanil consumptions were significantly decreased during 0-12 h and 12-24 h after operation, LSEQ scores on the morning of day 1 and QoR-15 scores at 24 and 48 h after operation were higher, full diet intakes achieved earlier in the ESPB group (all P<0.05). There were no significant differences in the incidences of intraoperative hypotension, postoperative dizziness, nausea, vomiting, and constipation between the 2 groups (all P>0.05). Providing favorable analgesic effects with reduced opioids consumption, bilateral ESPB for posterior lumbar spine surgery in the elderly patients could also improve postoperative sleep quality, promote gastrointestinal functional restoration, and enhance recovery with few adverse reactions.

Acute and long-term sleep measurements produce opposing results on sleep quality in 8 and 12 hour shift patterns in law enforcement officers.

The occupational demands of law enforcement increase the risk of poor-quality sleep, putting officers at risk of adverse physical and mental health. This cross-sectional study aimed to characterise sleep quality in day workers, 8 and 12 h rotating shift pattern workers. One hundred eighty-six officers volunteered for the study (37 female, age: 41 ± 7). Sleep quality was assessed using the Pittsburgh sleep quality index, actigraphy and the Leeds sleep evaluation questionnaire. The maximal aerobic capacity (VO2max ) was measured on a treadmill via breath-by-breath analysis. There was a 70% overall prevalence of poor sleepers based on Pittsburgh sleep quality index scores, where 8h shifts exhibited the worst prevalence (92%, p=0.029), however, there was no difference between age, gender, or role. In contrast, 12 h shifts exhibited the poorest short-term measures, including awakening from sleep (p=0.039) and behaviour following wakefulness (p=0.033) from subjective measures, and poorer total sleep time (p=0.024) and sleep efficiency (p=0.024) from the actigraphy. High VO2max predicted poorer wake after sleep onset (Rsq=0.07, p=0.05) and poorer sleep latency (p=0.028). There was no relationship between the Pittsburgh sleep quality index scores and any of the short-term measures. The prevalence of poor sleepers in this cohort was substantially higher than in the general population, regardless of shift pattern. The results obtained from the long- and short-term measures of sleep quality yielded opposing results, where long-term perceptions favoured the 12 h pattern, but short-term subjective and objective measures both favoured the 8h pattern.

Serotonin modifies the impact of sleep disturbance on suicidality in patients with acute coronary syndrome.

This study investigated the associations of sleep disturbance and serum serotonin levels with suicidal ideation, and evaluated the potential modifying effects of serotonin on these associations in patients with the acute coronary syndrome (ACS). In total, 969 ACS patients were recruited from a tertiary university hospital in Korea within 2 weeks of disease onset and evaluated in terms of sleep disturbance (using the Leeds Sleep Evaluation Questionnaire), serum serotonin levels, and suicidal ideation (using the "suicidal thoughts" item of the Montgomery-Åsberg Depression Rating Scale). Covariates included sociodemographics, depression, vascular risk factors, and disease severity. After 1 year, 711 patients were re-evaluated in terms of suicidal ideation. Logistic regression analysis was performed with adjustment for covariates. Sleep disturbance was significantly associated with suicidal ideation at baseline and follow-up. Serum serotonin showed no such association but modified the association of sleep disturbance with suicidal ideation such that it was significant only in the lower serum serotonin group, with significant interaction terms obtained after adjustment for relevant covariates. Evaluating sleep disturbance and serum serotonin levels could improve the accuracy of clinical predictions of suicidal ideation in the acute and chronic phases of ACS.

P009 The effects of low-dose morphine on sleep and breathlessness in chronic obstructive pulmonary disease

Abstract Introduction Low-dose morphine is prescribed for refractory breathlessness in chronic obstructive pulmonary disease (COPD). Preliminary investigations suggest improved perceived sleep quality, although concerns exist regarding opioid-induced sedation. This study assessed the effects of morphine on subjective sleep quality and alertness, and potential links between sleep quality and breathlessness. Methods Analysis of sleep questionnaire and breathlessness data at baseline and after one week of low-dose slow-release morphine versus placebo according to a double-blind randomised controlled design was performed. Participants were randomised to placebo, 8mg or 16mg/day oral morphine for one week (before further dose escalation). Epworth Sleepiness Scale (ESS), Karolinska Sleep Score (KSS), Leeds Sleep Evaluation Questionnaire (LSEQ) and breathlessness severity scores were assessed. Dose effects on sleep measures were assessed via linear regression (including baseline sleep measures). Drug effects on the relationship between sleep quality and breathlessness were assessed via linear mixed models with random effects and three-way interaction between sleep measures, dose, and visit. Results 156 patients were randomised as follows: 8mg, n=55; 16mg, n=51; placebo n=50. Overall, there was a neutral effect of morphine on ESS, KSS, and LSEQ (all p&amp;gt;0.05). Morphine did not modify the relationship between sleep measures and breathlessness. Discussion Despite safety concerns, one week of morphine did not negatively impact subjective sleep or daytime alertness measures. There was no clear relationship between morphine’s effects on sleep and next-day breathlessness perception. Objective data assessing sleep and next-day alertness are required to further explore potential links between sleep and breathlessness in people with COPD.

Change in Sleep Quality of Residents the Night Before High-Fidelity Simulation: Results From a Prospective 1-Year National Survey.

Objective:The stress level of participants in high-fidelity simulation stems from various factors but may result in anticipatory anxiety causing sleep disturbances during the night prior to simulation. The objective of this survey was to determine the change in sleep quality of residents during the night prior to the simulation.Methods:The survey was proposed for 1 year to all residents at the beginning of the simulation, in 10 simulation centres. The questionnaire combined demographics and the Leeds Sleep Evaluation Questionnaire using visual analogue scales divided into 4 sleep qualitative domains. The primary outcome was the prevalence of sleep disturbance (>10 mm on 1 domain). Secondary outcomes were the prevalence of severe sleep disturbance (>25 mm), as well as qualitatively and quantitatively reported explanatory sleep parameters.Results:Among respondents, 66% [95% CI: 63 to 69] of residents had more than 10 mm and 27% [95% CI: 24 to 30] had more than 25 mm of sleep disturbance. Residents with a sleep disturbance of more than 10 mm had fewer hours of sleep (6.4 [standard deviation = 1.8] vs 7.3 [standard deviation = 1.3], difference: −0.9 [95% CI: −1.1 to −0.7]; P < .0001), with a higher number of night-time awakenings (1.3 [standard deviation = 1.5] vs 0.7 [standard deviation = 0.9], difference: 0.6 [95% CI: 0.4 to 0.8]; P < .0001).Conclusion:Among residents participating in the simulation, a high prevalence of change in sleep quality during the night before the simulation was noted. Strategies to help residents achieve better sleep prior to simulation should be explored.

Orthopedic sleep and novel analgesia pathway: a prospective randomized controlled trial to advance recovery after shoulder arthroplasty.

Lack of sleep is associated with adverse effects on postsurgical pain and recovery. We hypothesized that a multimodal sleep pathway, including nonpharmacologic sleep hygiene interventions and the use of zolpidem and melatonin, could improve patient analgesia and sleep after total shoulder arthroplasty. We performed a prospective randomized controlled study in which patients undergoing anatomic and reverse total shoulder arthroplasty were treated with or without an interventional multimodal sleep pathway. This pathway included nursing-directed nonpharmacologic measures that promote sleep hygiene and pharmacologic interventions with low-dose zolpidem and melatonin at bedtime. All patients underwent a standardized multimodal analgesia protocol with scheduled acetaminophen, naproxen, and gabapentin, as well as a single-shot interscalene regional nerve block. This study enrolled 125 patients (64 in control group and 61 in interventional group) with similar demographic characteristics. The interventional group showed less oral morphine milligram equivalent (MME) consumption on postoperative day (POD) 0 (44.8±36.1 MMEs vs. 60.9±42.1 MMEs, P=.01) and showed a trend toward lower POD 0 visual analog scale pain scores (2.6±1.8 vs. 3.3±3.0, P=.06). Visual analog scale pain scores and MME consumption were similar on POD 1. The interventional group showed a longer objective sleep duration by quantitative wrist actigraphy (5.9±3.1 hours vs. 4.6±2.7 hours, P=.008), with better sleep quality assessed by the Leeds Sleep Evaluation Questionnaire (0-100 scale; 50.3±26.8 vs. 38.5±27.8, P=.01). The 2 groups showed similar satisfaction with pain management (89.2% vs. 79.6%, P=.16) and sleep management (82.1% vs. 76.8%, P=.48). There was no difference in the length of inpatient stay (32.2±14.8 hours vs. 34.1±12.8 hours, P=.44). In the setting of a regional and multimodal analgesia recovery plan for shoulder arthroplasty patients undergoing inpatient observation, the use of an interventional sleep pathway appears to be safe and beneficial, with improved analgesia, reduced opioid use, increased sleep duration, and improved reported sleep quality during the postoperative recovery period.

The Combination of Betahistine and Oxybutynin Increases Respiratory Control Sensitivity (Loop Gain) in People with Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial.

RationaleThere are widespread histaminergic projections throughout the brain, including hypoglossal nuclei, that modulate pharyngeal muscle tone and respiratory control. Hence, histaminergic stimulation pharmacologically may increase pharyngeal muscle tone and stabilize respiratory control (loop gain) to reduce obstructive sleep apnea (OSA) severity. Antimuscarinics also increase REM pharyngeal muscle tone in rats. Thus, a combination of histaminergic and anti-muscarinic drugs may be a novel target for OSA pharmacotherapy. However, this has not been investigated. Accordingly, we aimed to test the effects of betahistine (Beta), an H3-autoreceptor antagonist which thereby increases histamine levels, in combination with the antimuscarinic oxybutynin (Oxy), on OSA severity, OSA endotypes, polysomnography parameters and next-day sleepiness and alertness.MethodsThirteen adults with OSA received either Beta-Oxy (96–5mg) or placebo according to a randomized, crossover, double-blind design, prior to polysomnography. Participants completed the Karolinska Sleep Scale and Leeds Sleep Evaluation Questionnaire and a driving simulation task to quantify next-day sleepiness and alertness. OSA endotypes were estimated through validated algorithms using polysomnography.ResultsCompared to placebo, Beta-Oxy increased respiratory control sensitivity (loop gain) (0.52[0.24] vs 0.60[0.34], median [IQR], P = 0.021) without systematically changing OSA severity (34.4±17.2 vs 40.3±27.3 events/h, mean±SD, P = 0.124), sleep efficiency, arousal index or markers of hypoxemia. Beta-Oxy was well tolerated and did not worsen next-day sleepiness/alertness.ConclusionRather than stabilize breathing during sleep, Beta-Oxy increases loop gain, which is likely to be deleterious for most people with OSA. However, in certain conditions characterized by blunted respiratory control (eg, obesity hypoventilation syndrome), interventions to increase loop gain may be beneficial.

Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study

RationaleNovel compound with potent antagonistic activity against orexin receptors may be new treatment option for patients with insomnia.ObjectiveThe aim was to investigate the efficacy and safety of single oral doses of the dual orexin receptor antagonist TS-142 in patients with insomnia.MethodsThis multicenter, double-blind, crossover randomized clinical trial included non-elderly patients with insomnia. Patients were randomized to receive single doses of placebo and TS-142 at doses of 5, 10, and 30 mg in one of four different sequences, with a 7-day washout period between treatments. Primary efficacy endpoints were latency to persistent sleep (LPS) and wake time after sleep onset (WASO) measured by polysomnography.ResultsTwenty-four patients were included (mean age 50.3 ± 10.5 years; mean duration of insomnia 5.71 ± 8.68 years). Least-squares mean differences (95% confidence interval) from placebo in LPS with 5, 10, and 30 mg TS-142 were − 42.38 (− 60.13, − 24.63), − 42.10 (− 60.02, − 24.17), and − 44.68 (− 62.41, − 26.95) minutes, respectively (all p < 0.001). Least-squares mean differences (95% confidence interval) from placebo in WASO with 5, 10, and 30 mg TS-142 were − 27.52 (− 46.90, − 8.14), − 35.44 (− 55.02, − 15.87), and − 54.69 (− 74.16, − 35.23) minutes, respectively (all p < 0.01). Self-reported aspects of sleep initiation and sleep quality, determined using the Leeds Sleep Evaluation Questionnaire (LSEQ), were also improved with TS-142 administration versus placebo. TS-142 was well tolerated; all adverse events were mild or moderate and none were serious.ConclusionSingle-dose TS-142 was well tolerated and had clinically relevant effects on objective and subjective sleep parameters in patients with insomnia.Clinical Trial registrationJapicCTI173570 (www.clinicaltrials.jp); NCT04573725 (www.clinicaltrials.gov).

Yangshimtang-gamibang Therapy for Sleep Disorder Caused by a Traffic Accident: A Case Report

This report describes the efficacy of using &lt;i&gt;Yangshimtang-gamibang&lt;/i&gt; for a sleep disorder caused by a traffic accident. We treated a patient with &lt;i&gt;Yangshimtang-gamibang&lt;/i&gt; for 12 days for sleep disorder caused by a traffic accident. To evaluate the results, we used the Korean Modified Leeds Sleep Evaluation Questionnaire (KMLSEQ) to measure sleep disorder. The degree of sleep disorder was also evaluated using the Numerical Rating Scale (NRS). The generic health status was evaluated using the European Quality of Life-5 Dimensions (EQ-5D) scale. Improvements in the NRS and EQ-5D scale scores were observed after the treatments. The change in the KMLSEQ score indicates that the patient's sleep disorder was relieved. The results of this case study suggest that &lt;i&gt;Yangshimtang-gamibang&lt;/i&gt; may be an effective treatment for sleep disorders caused by traffic accident.

Melatonin effects on sleep quality and outcomes of COVID-19 patients: An open-label, randomized, controlled trial.

This trial aims to evaluate the effectiveness of adding melatonin to the treatment protocol of hospitalized coronavirus disease 2019 (COVID‐19) patients. This was an open‐label, randomized controlled clinical trial in hospitalized COVID‐19 patients. Patients were randomized into a treatment arm receiving melatonin plus standard care or a control arm receiving standard care alone. The trial's primary endpoint was sleep quality examined by the Leeds Sleep Evaluation Questionnaire (LSEQ). The trial's secondary endpoints were symptoms alleviation by Day 7, intensive care unit admission, 10‐day mortality, white blood cell count, lymphocyte count, C‐reactive protein status, and peripheral capillary oxygen saturation. Ninety‐six patients were recruited and allocated to either the melatonin arm (n = 48) or control arm (n = 48). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms on Day 7. The mean of the LSEQ scores was significantly higher in the melatonin group (p < 0.001). There was no significant difference in laboratory data, except for blood oxygen saturation, which has improved significantly in the melatonin group compared with the control group (95.81% vs. 93.65% respectively, p = 0.003). This clinical trial study showed that the combination of oral melatonin tablets and standard treatment could substantially improve sleep quality and blood oxygen saturation in hospitalized COVID‐19 patients.

Temporal dynamics of subjective sleep profiles predicting mood improvements during adjunctive light therapy combined with sleep rescheduling

• Sleep-enhancement following light therapy may contribute to rapid mood improvements. • Subsequent alleviation of sleep-related daytime dysfunction may further improve mood. • Self-reported sleep variables may predict antidepressant response to light therapy. Light therapy yields inconsistent results in people with non-seasonal depression, which may in part be due to heterogeneous responses and the temporal dynamics of changes in sleep, daytime functioning and mood. This study assessed the timeline of the antidepressant effects of light therapy and sleep rescheduling relative to changes in sleep and daytime sleep-related factors, and sought to identify predictors of treatment response in young people with depression. Twenty-four individuals with depression (mean±SD: 21.2±1.0 years old;17% male) underwent adjunctive morning light therapy with a wake-up phase advance over four weeks. They completed the Beck Depression Inventory-II (BDI-II) and Leeds Sleep Evaluation Questionnaire. On average, BDI-II scores decreased significantly after four weeks of intervention ( F (2,32)=3.5, p =.044, ηp 2 =0.18). After two weeks, improvements in the ease of getting to sleep and sleep quality were significantly associated with BDI-II improvements ( F (2,21)=6.3, p =.007). From two to four weeks, improvements in daytime sleep-related factors were significantly associated with BDI-II improvements ( F (2,12)=6.0, p =.015). More sleep-related difficulties prior to the intervention tended to predict BDI-II improvements across the four weeks of light therapy ( F (2,14)=3.7, p =.053). Open-label design and small sample size. Sleep-enhancement emerging in the early phase of light therapy and sleep rescheduling may subsequently alleviate sleep-related daytime dysfunctions, which may in turn further improve mood. Controlled trials are required to confirm whether the antidepressant effects of light may be linked to the attenuation of sleep-related difficulties, and whether sleep difficulties may be useful predictors of the antidepressant response to light therapy.

Measuring Subjective Sleep Quality: A Review.

Sleep quality is an important clinical construct since it is increasingly common for people to complain about poor sleep quality and its impact on daytime functioning. Moreover, poor sleep quality can be an important symptom of many sleep and medical disorders. However, objective measures of sleep quality, such as polysomnography, are not readily available to most clinicians in their daily routine, and are expensive, time-consuming, and impractical for epidemiological and research studies., Several self-report questionnaires have, however, been developed. The present review aims to address their psychometric properties, construct validity, and factorial structure while presenting, comparing, and discussing the measurement properties of these sleep quality questionnaires. A systematic literature search, from 2008 to 2020, was performed using the electronic databases PubMed and Scopus, with predefined search terms. In total, 49 articles were analyzed from the 5734 articles found. The psychometric properties and factor structure of the following are reported: Pittsburgh Sleep Quality Index (PSQI), Athens Insomnia Scale (AIS), Insomnia Severity Index (ISI), Mini-Sleep Questionnaire (MSQ), Jenkins Sleep Scale (JSS), Leeds Sleep Evaluation Questionnaire (LSEQ), SLEEP-50 Questionnaire, and Epworth Sleepiness Scale (ESS). As the most frequently used subjective measurement of sleep quality, the PSQI reported good internal reliability and validity; however, different factorial structures were found in a variety of samples, casting doubt on the usefulness of total score in detecting poor and good sleepers. The sleep disorder scales (AIS, ISI, MSQ, JSS, LSEQ and SLEEP-50) reported good psychometric properties; nevertheless, AIS and ISI reported a variety of factorial models whereas LSEQ and SLEEP-50 appeared to be less useful for epidemiological and research settings due to the length of the questionnaires and their scoring. The MSQ and JSS seemed to be inexpensive and easy to administer, complete, and score, but further validation studies are needed. Finally, the ESS had good internal consistency and construct validity, while the main challenges were in its factorial structure, known-group difference and estimation of reliable cut-offs. Overall, the self-report questionnaires assessing sleep quality from different perspectives have good psychometric properties, with high internal consistency and test-retest reliability, as well as convergent/divergent validity with sleep, psychological, and socio-demographic variables. However, a clear definition of the factor model underlying the tools is recommended and reliable cut-off values should be indicated in order for clinicians to discriminate poor and good sleepers.

Cannabinoids in the Treatment of Insomnia Disorder: A Systematic Review and Meta-Analysis.

Insomnia is associated with significant comorbidity, disability and impact on quality of life and, despite advances in pharmacotherapy and psychotherapy, remains a significant burden to society. Cannabinoids are gaining acceptance for use as medicines in the treatment of insomnia disorder. We conducted a systematic review and meta-analysis to evaluate the efficacy of cannabinoids in the treatment of insomnia disorder. We performed a systematic review of the PubMed, Cochrane Library, MEDLINE, and Cumulative Index to Nursing and Allied Health Literature Complete databases from inception to 5 December 2019, and again prior to data abstraction, for studies of cannabis-based products for the treatment of insomnia disorder in adults. Inclusion criteria were (1) clinical studies, (2) participants aged ≥18years, (3) insomnia disorder either formally diagnosed against contemporaneous diagnostic criteria or quantified with validated instruments and (4) compared cannabis-based products with the standard of care, placebo or a sedative. No language restrictions were imposed. Non-primary research, animal studies and studies of cannabis-induced insomnia were excluded. Risk of bias was assessed using the RoB 2 tool for randomised controlled trials (RCTs) and Risk of Bias in Non-randomized Studies-of Interventions (ROBINS-I) tool for non-randomized trials. Heterogeneity was assessed with the I2 statistic. A total of five studies (two RCTs and three non-randomised studies) with 219 study participants were included, of which three could be combined. The three non-randomised studies contributed data on the Pittsburgh Sleep Quality Index Questionnaire score, showing a favourable effect of cannabinoids at ≤4weeks of follow-up (mean difference -1.89 [95% confidence interval {CI} -2.68 to -1.10]; n=176) and at 8 weeks of follow-up (mean difference -2.41 [95% CI -3.36 to -1.46]; n=166). One double-blind crossover RCT (n=32) reported that, compared with amitriptyline, nabilone-a synthetic analogue to tetrahydrocannabinol (THC)-improved Insomnia Severity Index scores after 2 weeks of treatment (adjusted difference -3.25 [95% CI -5.26 to -1.24]) and resulted in a more restful sleep as a sub-measure of the Leeds Sleep Evaluation Questionnaire (LSEQ) (difference 0.48 [95% CI 0.01-0.95]) but with no effect on overall sleep quality as measured by the LSEQ. In a single ascending-dose RCT (n=9), THC reduced sleep-onset latency compared with placebo at 10mg, 20mg and 30mg doses (mean difference -43.00min [95% CI -82.76 to -3.24], -62.00 [95% CI -103.60 to -20.40] and -54.00 [95% CI -103.93 to -4.07], respectively). All the included studies were assessed as poor quality, mainly due to small sample sizes, short treatment periods, uncertain clinical significance and high risk of bias. Few studies have examined the efficacy of cannabinoids in the treatment of insomnia disorder. Despite some possible signals for efficacy, the heterogeneity of participants, interventions, efficacy outcomes and results, and the high risk of bias across included trials, do not reliably inform evidence-based practice. This review highlights shortcomings in the existing literature, including lack of diagnostic clarity, poorly defined participant groups, non-standardised interventions and studies of inappropriate design, duration and power to detect clinically meaningful outcomes. Further research in the form of high-quality RCTs are required before drawing any conclusions about the efficacy of cannabinoids in the treatment of insomnia disorder. PROSPERO registration number, CRD42020161043.

Sleep during Mohs micrographic surgery: A prospective study.

Mohs micrographic surgery (MMS) is a highly specialized technique for treating skin cancer. Drawbacks of MMS are the multi-step procedure and long surgery time. Some patients sleep during surgery and involuntary movements during sleeping can interfere with surgery, which increases the risk of a fall injury. However, to our knowledge, there have been no studies regarding the characteristics of patients' sleep during MMS. This study aimed to investigate the prevalence and characteristics of sleeping patients during MMS. We performed a prospective study and included patients with skin cancers impending MMS. All patients rated their anxiety levels and sleep status using the State-Trait Anxiety Inventory, an anxiety visual analog scale, the Pittsburgh Sleep Quality Index, and the Leeds Sleep Evaluation Questionnaire. Our data showed that 21.9% of patients were asleep during MMS. Multivariable analysis showed that older age (odds ratio [OR], 1.142; p=0.003), lesion size >150 mm2 (OR, 7.904; p=0.031), and multi-stage MMS (OR, 12.201; p=0.011) were significantly associated factors of sleep. This study is the first to report the prevalence and associated factors of sleep during MMS. Physicians should monitor patients with risk factors during MMS to prevent possible medical accidents.

Is poor self-rated sleep quality associated with elevated systemic inflammation in healthy older adults?

ObjectiveExamine subjective sleep quality and inflammation among healthy older adults participating in the Australian Research Council Longevity Intervention (ARCLI). MethodsData was taken from a sub-set of 232 participants aged between 60–70 years (M = 65.88 ± SD 4.08 years) who participated in the baseline assessment phase of the Australian Research Council Longevity Intervention (ARCLI) study. Subjective sleep was assessed via the Leeds Sleep Evaluation Questionnaire (LSEQ). Inflammatory markers (TNF-α, IL-1β, IL-6, IL-10, IL-2, IFN-γ, IL-4, hs-CRP) were derived from whole blood. Correlation and multiple regression analyses were used to examine associations between each of the four sleep outcome variables and inflammatory outcomes, examined as a group and following gender stratification. ResultsDifficulties getting to sleep were independently associated with higher IL-2 [F(1,156) = 4.62, adjusted R2 = 0.02, p = 0.03] and IL-1β [F(1,141) = 8.52, adjusted R2 = 0.05, p = 0.004] (whole group). Difficulties getting to sleep were associated with greater IL-1β [males: F(1,58) = 7.36, adjusted R2 = 0.097 p = 0.009; females: F (1,81) = 4.25, R2 = 0.038, p = 0.04], and negatively associated with hs-CRP (women) [F (1,129) = 4.71, R2 = 0.028, p = 0.032]. DiscussionSubjective sleep-onset difficulties are associated with systemic inflammation.