Patient-reported Sleep Disturbance Research Articles

Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials

BackgroundPatient-focused approaches to capturing day-to-day variability in sleep disturbance are needed to properly evaluate the sleep benefits of new treatments. Such approaches rely on patient-reported outcome (PRO) measures validated in the target patient population.MethodsUsing atopic dermatitis (AD) as an example of a disease in which sleep is commonly disturbed, we developed a strategy for measuring sleep disturbance in AD trials. In developing this strategy, we conducted a targeted literature review and held concept elicitation interviews with adolescents and adults with AD. We subsequently identified potentially suitable PRO measures and cognitively debriefed them. Finally, we evaluated their psychometric properties using data from phase 2b (NCT03100344) and phase 3 (NCT03985943 and NCT03989349) clinical trials.ResultsThe literature review confirmed that sleep disturbance is a key impact of AD but failed to identify validated PRO measures for assessing fluctuations in sleep disturbance. Subsequent concept elicitation interviews confirmed the multidimensional nature of sleep disturbance in AD and supported use of a single-item measure to assess overall sleep disturbance severity, complemented by a diary to capture individual components of sleep disturbance. The single-item sleep disturbance numerical rating scale (SD NRS) and multi-item Subject Sleep Diary (SSD)—an AD-adapted version of the Consensus Sleep Diary—were identified as potentially suitable PRO measures. Cognitive debriefing of the SD NRS and SSD demonstrated their content validity and their understandability to patients. Psychometric analyses based on AD trial data showed that the SD NRS is a well-defined, reliable, and fit-for-purpose measure of sleep disturbance in adults with AD. Furthermore, the SD NRS correlated with many SSD sleep parameters, suggesting that most concepts from the SSD can be covered using the SD NRS.ConclusionsUsing these findings, we developed an approach for measuring sleep disturbance in AD trials. Subject to further research, the same approach could also be applied to future trials of other skin diseases where itch causes sleep disturbance.

MP29-15 REMOTELY-MONITORED SLEEP MEASURES IN PROSTATE CANCER PATIENTS UNDERGOING ANDROGEN DEPRIVATION THERAPY (ADT)

You have accessJournal of UrologyCME1 Apr 2023MP29-15 REMOTELY-MONITORED SLEEP MEASURES IN PROSTATE CANCER PATIENTS UNDERGOING ANDROGEN DEPRIVATION THERAPY (ADT) Brandon Noorvash, Aubrey Jarman, Carolina Raines, Edwin M. Posadas, Howard M. Sandler, Stephen J. Freedland, and Gillian Gresham Brandon NoorvashBrandon Noorvash More articles by this author , Aubrey JarmanAubrey Jarman More articles by this author , Carolina RainesCarolina Raines More articles by this author , Edwin M. PosadasEdwin M. Posadas More articles by this author , Howard M. SandlerHoward M. Sandler More articles by this author , Stephen J. FreedlandStephen J. Freedland More articles by this author , and Gillian GreshamGillian Gresham More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003257.15AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Sleep disturbance is a common symptom experienced among men with prostate cancer (PC) undergoing ADT that can lead to increased fatigue, diminished quality of life, and poor clinical outcomes. Wearable activity monitors (e.g. Fitbits) allow for objective measures of sleep outside the clinical setting. Despite its importance, there is a current lack of information supporting the use of commercially available wearables for sleep monitoring among PC patients. Thus, we evaluated remotely-monitored longitudinal sleep measures in PC patients receiving ADT. METHODS: PC patients initiating ADT and recruited from Cedars-Sinai and the Durham VA wore a Fitbit Charge HR continuously for 8 weeks to capture daily activity and sleep and monthly electronic patient-reported sleep disturbance (NIH PROMIS survey) and insomnia (PRO-CTCAE). Objective and patient-reported sleep data were summarized, and changes were calculated at 4 and 8 weeks from baseline. RESULTS: A total of 25 patients were included in the analysis (median age 69, range 51-85, 64% Non-Hispanic White, 16% Black, 20% other race/ethnicity). Adherence to wearing the device was 100% at baseline, 88% at 4 weeks, and 76% at week 8. Sleep measures are summarized in /Table 1/. Objective sleep duration decreased over time (-1.5 hours at 8 weeks, p=0.02) and the number of sleep disturbances increased, although not statistically significant. Severity and interference of patient-reported insomnia (PRO-CTCAE) also worsened over time (Table 1). CONCLUSIONS: Our findings suggest that the use of wearables to remotely monitor sleep is feasible in PC patients. Sleep duration and quality were poor and worsened over time, with many awakenings and segmented sleep, which may be associated with treatment effects and other symptoms (e.g., hot flashes, nocturia). More research is needed to inform the development of tailored interventions to improve sleep in this population. Source of Funding: Department of Defense © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e387 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Brandon Noorvash More articles by this author Aubrey Jarman More articles by this author Carolina Raines More articles by this author Edwin M. Posadas More articles by this author Howard M. Sandler More articles by this author Stephen J. Freedland More articles by this author Gillian Gresham More articles by this author Expand All Advertisement PDF downloadLoading ...

0130 Central and Peripheral Markers of Oxidative Stress and Sleep in Mood Disorder: A Pilot MR Spectroscopy Study

Abstract Introduction Sleep disturbance is both a symptom of and a risk factor for mood disorders. Oxidative stress may impact the relationship between sleep disturbance and mood. However, the relationships between sleep and in vivo measurements of oxidative stress in the brain have not been examined in humans. Therefore, we tested the relationship between patient-reported sleep disturbance with peripheral and central concentrations of glutathione (GSH), the primary antioxidant in the brain. Methods Participants (2 women and 7 men) were individuals with (n=2) and without mood disorder (n=7), ages 35-61 years. MR spectroscopy at 7 Tesla (TE=20ms, TM=10ms, TR=3000ms) was used to measure cortical GSH levels in the brain in the anterior cingulate cortex (ACC), ventromedial prefrontal cortex (VMPFC), and dorsolateral prefrontal cortex (DLPFC). Peripheral GSH was assayed from a fasted morning blood draw. Sleep disturbance and related impairment was assessed via the PROMIS Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI) questionnaires. Pearson correlations were assessed between peripheral and central GSH levels with PROMIS-SD and PROMIS-SRI T-scores. Results We observed significant negative correlations between DLPFC GSH with sleep disturbance (r=-0.744, p=0.022) and sleep-related impairment (r=-0.753, p=0.019). We did not detect correlations between sleep-related endpoints and peripheral GSH levels or GSH levels in the ACC or VMPFC. Conclusion These preliminary results suggest that more sleep disturbance and related impairment may be associated with lower levels of cortical GSH and implicate a role for sleep disturbance to impact oxidative stress in a region associated with rapid eye movement sleep and modulation of affective states. Support (If Any) This work was supported by grants from the National Institutes of Health R01MH110979 (PBM) and T32MH017119 (JB).

Patient-reported sleep disturbance in advanced cancer: frequency, predictors and screening performance of the Edmonton Symptom Assessment System sleep item

AimsSleep Disturbance (SD) is a severe debilitating symptom in advanced cancer patients (ACP). However, routine screening of SD is uncommon. The primary aim of this study was to determine the...

Sleep Patterns During Hospitalization Following Hematopoietic Stem Cell Transplantation.

To characterize patient-reported and objective sleep assessments and provide a preliminary examination of the relationships among sleep, quality of life, and demographic or treatment factors. A secondary data analysis using a descriptive-correlational design. University of Illinois Hospital and Health Sciences System. 40 patients undergoing a hematopoietic stem cell transplantation (HCT) hospitalized for the conditioning regimen, stem cell infusion, and immediate recovery period. Each patient wore a wrist actigraph continuously from the fourth day following HCT to the eighth day to objectively assess sleep patterns (total sleep time, sleep onset latency, sleep efficiency, wake after sleep onset, and number of awakenings). At the end of the five-day period, patients completed measures of sleep disturbance and quality of life. Objective sleep (total sleep time, sleep onset latency, sleep efficiency, wake after sleep onset, and number of awakenings), subjective sleep (sleep disturbance), and quality of life. The mean total nighttime sleep (objectively obtained) was 232 minutes (SD = 71 minutes), with 14 patients (35%) sleeping less than three consecutive hours during one or more study days. Age was negatively correlated with patient-reported sleep disturbance. Patient-reported sleep disturbance was significantly associated with length of hospital stay. No correlations were found between patient-reported and objective sleep assessments. This study objectively documents inadequate and irregular sleep in hospitalized patients undergoing HCT. Sole reliance on patient-reported sleep assessments may not represent the full extent of the problem. Attempts to streamline care during the night by not waking patients for routine care unless indicated by the patient's condition (as advocated by the American Academy of Nursing) and providing supportive care for symptoms (such as diarrhea) during the night may reduce the number of awakenings and possibly improve overall sleep quality.

Myasthenia gravis: Sleep quality, quality of life, and disease severity

There is much research on quality of life in myasthenia gravis (MG), and its relationship to disease severity is well-established. However, evidence regarding sleep disturbance in MG is inconclusive. To evaluate sleep and quality of life among clinically stable MG patients, 54 subjects were investigated by means of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS) and 15-Item-Quality-Of-Life Instrument for MG (MG-QOL15). A pathological PSQI score, which was observed in 59% of patients, was increased in subjects with active disease compared with patients in clinical remission [odds ratio = 4.3; confidence interval 95% (1.0-17.6); P = 0.04]. We found a relationship between PSQI and MG-QOL15 scores in patients with clinically active disease (r = 0.62; P < 0.001). Our study highlights the high prevalence of sleep disturbance among MG patients. Disease severity may be considered to be a MG-specific risk factor for patient-reported sleep disturbance. The MG-QOL15 and PSQI should be used to estimate the impact of the disease on sleep and quality of life.

Efficacy of an intervention for fatigue and sleep disturbance during cancer chemotherapy.

Multiple complex symptoms from cancer treatment can interfere with functioning. To evaluate the efficacy of an "energy and sleep enhancement" (EASE) intervention to relieve fatigue and sleep disturbance and improve health-related functional status. Individuals receiving chemotherapy (CTX) were randomized to the EASE (n=153) or a control intervention (n=139). The EASE intervention included information and behavioral skills taught by an oncology nurse in three telephone sessions. The primary outcomes of fatigue, sleep disturbance, and functional status were measured before CTX, Day 4 after first treatment (baseline), and 43-46 or 57-60 days later (follow-up), depending on the CTX cycle length. The sample was primarily female (82%) and non-Hispanic white (89%), with mean age of 53.9 years. Fatigue and patient-reported sleep disturbance were elevated in both groups at baseline and follow-up. Actigraphy revealed that the total sleep time was almost eight hours, and sleep percent was greater than 85% for both groups at both time points (normal range). Physical functioning was diminished and at the same level as a sample with serious illness. Mental functioning was in normal range. A repeated-measures analysis of variance revealed no statistically significant group-by-time effects for fatigue, sleep disturbance, or functional status. Unemployed individuals showed greater benefit from the EASE intervention, reporting less pain and symptom interference. Potential explanations include high variability and/or floor effect for fatigue, incorrect timing of measures, insufficient amount or dose of the intervention, and confounding effects of gender. Future research should consider screening for symptom severity and tailoring interventions.