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International Journal of Yoga Therapy Jan 2021Extended sleep onset latency (SOL), or "sleep onset insomnia," can decrease total sleep time, increasing risk for many health conditions, including heart disease,... (Randomized Controlled Trial)
Randomized Controlled Trial
Extended sleep onset latency (SOL), or "sleep onset insomnia," can decrease total sleep time, increasing risk for many health conditions, including heart disease, stroke, and all-cause mortality. Sleep disorders persist in the United States despite current behavioral/pharmaceutical remedies, with 10% to 15% of the population suffering from insomnia. Mind-body therapies offer additional solutions, as meditation has been correlated with decreased SOL. More research on use of mind-body practices for insomnia is needed. This study investigates the guided meditation practice of Yoga Nidra (yogic sleep) as a promising intervention for sleep disorders because of its purported ability to induce mental, physical, and emotional relaxation. In this pilot study, we address the feasibility of Yoga Nidra for insomnia, appropriateness of our selected measurement systems, and effect of Yoga Nidra on brainwaves, sleep onset, and the autonomic nervous system. Our study sample includes 22 adults, ages 18-45, with insomnia. The design includes two clinic visits (V1, lying quietly for 90 min; V2, randomization to 90-min lying quietly vs. 30-min Yoga Nidra plus 60-min lying quietly), taking place 1 to 14 days apart. Outcomes measured during/after Yoga Nidra (vs. control) include sleep onset, electroencephalography (EEG) power, heart rate variability (HRV), and respiratory rate. Self-reported mood and anxiety will be measured before/after each visit. Resulting physiological, psychological, and feasibility data will be used to inform future clinical studies of Yoga Nidra for sleep and relaxation.
Topics: Adolescent; Adult; Humans; Meditation; Middle Aged; Pilot Projects; Sleep; Sleep Initiation and Maintenance Disorders; Yoga; Young Adult
PubMed: 33175980
DOI: 10.17761/2021-D-20-00004 -
JAMA Network Open Mar 2022Despite the legalization and widespread use of cannabis products for a variety of medical concerns in the US, there is not yet a strong clinical literature to support... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Despite the legalization and widespread use of cannabis products for a variety of medical concerns in the US, there is not yet a strong clinical literature to support such use. The risks and benefits of obtaining a medical marijuana card for common clinical outcomes are largely unknown.
OBJECTIVE
To evaluate the effect of obtaining a medical marijuana card on target clinical and cannabis use disorder (CUD) symptoms in adults with a chief concern of chronic pain, insomnia, or anxiety or depressive symptoms.
DESIGN, SETTING, AND PARTICIPANTS
This pragmatic, single-site, single-blind randomized clinical trial was conducted in the Greater Boston area from July 1, 2017, to July 31, 2020. Participants were adults aged 18 to 65 years with a chief concern of pain, insomnia, or anxiety or depressive symptoms. Participants were randomized 2:1 to either the immediate card acquisition group (n = 105) or the delayed card acquisition group (n = 81). Randomization was stratified by chief concern, age, and sex. The statistical analysis followed an evaluable population approach.
INTERVENTIONS
The immediate card acquisition group was allowed to obtain a medical marijuana card immediately after randomization. The delayed card acquisition group was asked to wait 12 weeks before obtaining a medical marijuana card. All participants could choose cannabis products from a dispensary, the dose, and the frequency of use. Participants could continue their usual medical or psychiatric care.
MAIN OUTCOMES AND MEASURES
Primary outcomes were changes in CUD symptoms, anxiety and depressive symptoms, pain severity, and insomnia symptoms during the trial. A logistic regression model was used to estimate the odds ratio (OR) for CUD diagnosis, and linear models were used for continuous outcomes to estimate the mean difference (MD) in symptom scores.
RESULTS
A total of 186 participants (mean [SD] age 37.2 [14.4] years; 122 women [65.6%]) were randomized and included in the analyses. Compared with the delayed card acquisition group, the immediate card acquisition group had more CUD symptoms (MD, 0.28; 95% CI, 0.15-0.40; P < .001); fewer self-rated insomnia symptoms (MD, -2.90; 95% CI, -4.31 to -1.51; P < .001); and reported no significant changes in pain severity or anxiety or depressive symptoms. Participants in the immediate card acquisition group also had a higher incidence of CUD during the intervention (17.1% [n = 18] in the immediate card acquisition group vs 8.6% [n = 7] in the delayed card acquisition group; adjusted odds ratio, 2.88; 95% CI, 1.17-7.07; P = .02), particularly those with a chief concern of anxiety or depressive symptoms.
CONCLUSIONS AND RELEVANCE
This randomized clinical trial found that immediate acquisition of a medical marijuana card led to a higher incidence and severity of CUD; resulted in no significant improvement in pain, anxiety, or depressive symptoms; and improved self-rating of insomnia symptoms. Further investigation of the benefits of medical marijuana card ownership for insomnia and the risk of CUD are needed, particularly for individuals with anxiety or depressive symptoms.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03224468.
Topics: Adolescent; Adult; Aged; Female; Humans; Medical Marijuana; Middle Aged; Mood Disorders; Ownership; Pain; Single-Blind Method; Sleep Initiation and Maintenance Disorders; Young Adult
PubMed: 35302633
DOI: 10.1001/jamanetworkopen.2022.2106 -
JAMA Network Open Mar 2023Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking.
OBJECTIVE
To investigate the efficacy of a smartphone-based Chinese culture-adapted DCBT-I application (app) for insomnia compared with sleep education using the same app.
DESIGN, SETTING, AND PARTICIPANTS
This was a single-blinded, randomized clinical trial conducted from March 2021 to January 2022. Screening and randomization were conducted at Peking University First Hospital. Follow-up visits were performed online or in the same hospital. After assessing for eligibility, eligible participants were enrolled and allocated (1:1) to DCBT-I or sleep education groups. Data were analyzed from January to February 2022.
INTERVENTIONS
A Chinese smartphone-based app with the same interface was used in both DCBT-I and sleep education groups over 6 weeks, with 1-, 3-, and 6-month follow-ups.
MAIN OUTCOMES AND MEASURES
The primary outcome was Insomnia Severity Index (ISI) scores with the intention-to-treat principle. Secondary and exploratory outcomes included sleep diary measures; self-reported scales assessing dysfunctional beliefs about sleep, mental health, and quality of life; and smart bracelet measures.
RESULTS
Of 82 participants (mean [SD] age, 49.67 [14.49] years; 61 [74.4%] females), with 41 randomized to sleep education and 41 randomized to DCBT-I; 77 participants completed the 6-week intervention (39 participants in the sleep education group and 38 participants in the DCBT-I group; full analysis data set) and 73 completed the 6-month follow-up (per protocol data set). Mean (SD) ISI scores in the DCBT-I group were significantly lower than those in the sleep education group after the 6-week intervention (12.7 [4.8] points vs 14.9 [5.0] points; Cohen d = 0.458; P = .048) and at the 3-month follow-up (12.1 [5.4] points vs 14.8 [5.5] points; Cohen d = 0.489; P = .04). There were significant improvements from before to after the intervention for both the sleep education and DCBT-I groups, with large effect sizes(sleep education: d = 1.13; DCBT-I: d = 1.71). Some of the sleep diary measures and self-reported scales showed more improvements in the DCBT-I group than sleep education group, such as total sleep time (mean [SD]: 3 months, 403.9 [57.6] minutes vs 363.2 [72.3] minutes; 6 months, 420.3 [58.0] minutes vs 389.7 [59.4] minutes) and sleep efficiency (mean [SD]: 3 months, 87.4% [8.3%] vs 76.7% [12.1%]; 6 months, 87.5% [8.2%] vs 78.1% [10.9%]).
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial, the smartphone-based Chinese culture-adapted DCBT-I improved insomnia severity compared with sleep education. Future multicenter clinical trials with large sample sizes are needed to validate its effectiveness in the Chinese population.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04779372.
Topics: Female; Humans; Middle Aged; Male; Sleep Initiation and Maintenance Disorders; Quality of Life; Treatment Outcome; Mobile Applications; Smartphone; Pilot Projects; Cognitive Behavioral Therapy
PubMed: 36972049
DOI: 10.1001/jamanetworkopen.2023.4866 -
JAMA Psychiatry Apr 2024Chronic insomnia disorder is highly prevalent, disabling, and costly. Cognitive behavioral therapy for insomnia (CBT-I), comprising various educational, cognitive, and... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Chronic insomnia disorder is highly prevalent, disabling, and costly. Cognitive behavioral therapy for insomnia (CBT-I), comprising various educational, cognitive, and behavioral strategies delivered in various formats, is the recommended first-line treatment, but the effect of each component and delivery method remains unclear.
OBJECTIVE
To examine the association of each component and delivery format of CBT-I with outcomes.
DATA SOURCES
PubMed, Cochrane Central Register of Controlled Trials, PsycInfo, and International Clinical Trials Registry Platform from database inception to July 21, 2023.
STUDY SELECTION
Published randomized clinical trials comparing any form of CBT-I against another or a control condition for chronic insomnia disorder in adults aged 18 years and older. Insomnia both with and without comorbidities was included. Concomitant treatments were allowed if equally distributed among arms.
DATA EXTRACTION AND SYNTHESIS
Two independent reviewers identified components, extracted data, and assessed trial quality. Random-effects component network meta-analyses were performed.
MAIN OUTCOMES AND MEASURES
The primary outcome was treatment efficacy (remission defined as reaching a satisfactory state) posttreatment. Secondary outcomes included all-cause dropout, self-reported sleep continuity, and long-term remission.
RESULTS
A total of 241 trials were identified including 31 452 participants (mean [SD] age, 45.4 [16.6] years; 21 048 of 31 452 [67%] women). Results suggested that critical components of CBT-I are cognitive restructuring (remission incremental odds ratio [iOR], 1.68; 95% CI, 1.28-2.20) third-wave components (iOR, 1.49; 95% CI, 1.10-2.03), sleep restriction (iOR, 1.49; 95% CI, 1.04-2.13), and stimulus control (iOR, 1.43; 95% CI, 1.00-2.05). Sleep hygiene education was not essential (iOR, 1.01; 95% CI, 0.77-1.32), and relaxation procedures were found to be potentially counterproductive(iOR, 0.81; 95% CI, 0.64-1.02). In-person therapist-led programs were most beneficial (iOR, 1.83; 95% CI, 1.19-2.81). Cognitive restructuring, third-wave components, and in-person delivery were mainly associated with improved subjective sleep quality. Sleep restriction was associated with improved subjective sleep quality, sleep efficiency, and wake after sleep onset, and stimulus control with improved subjective sleep quality, sleep efficiency, and sleep latency. The most efficacious combination-consisting of cognitive restructuring, third wave, sleep restriction, and stimulus control in the in-person format-compared with in-person psychoeducation, was associated with an increase in the remission rate by a risk difference of 0.33 (95% CI, 0.23-0.43) and a number needed to treat of 3.0 (95% CI, 2.3-4.3), given the median observed control event rate of 0.14.
CONCLUSIONS AND RELEVANCE
The findings suggest that beneficial CBT-I packages may include cognitive restructuring, third-wave components, sleep restriction, stimulus control, and in-person delivery but not relaxation. However, potential undetected interactions could undermine the conclusions. Further large-scale, well-designed trials are warranted to confirm the contribution of different treatment components in CBT-I.
Topics: Adult; Humans; Female; Middle Aged; Male; Sleep Initiation and Maintenance Disorders; Network Meta-Analysis; Cognitive Behavioral Therapy; Sleep; Treatment Outcome
PubMed: 38231522
DOI: 10.1001/jamapsychiatry.2023.5060 -
Journal of Clinical Oncology : Official... Nov 2021Younger women are at risk for depression and related symptoms following breast cancer. The Pathways to Wellness study, a randomized, multi-institution, three-arm trial,... (Randomized Controlled Trial)
Randomized Controlled Trial
Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education.
PURPOSE
Younger women are at risk for depression and related symptoms following breast cancer. The Pathways to Wellness study, a randomized, multi-institution, three-arm trial, tested the efficacy of two behavioral interventions for younger breast cancer survivors with elevated depressive symptoms: mindful awareness practices (MAPs) and survivorship education (SE) (Clincaltrials.gov identifier: NCT03025139).
METHODS
Women diagnosed with breast cancer at or before 50 years of age who had completed treatment and had elevated depressive symptoms were randomly assigned to 6 weeks of MAPs, SE, or wait-list control (WLC). Assessments were conducted preintervention and postintervention and at 3-month and 6-month postintervention follow-ups. Analyses compared each intervention to WLC using linear mixed models. The primary outcome was change in depressive symptoms from preintervention to postintervention on the Center for Epidemiologic Studies-Depression Scale; secondary outcomes included change in fatigue, insomnia, and vasomotor symptoms.
RESULTS
Two hundred forty-seven women (median age = 46 years) were randomly assigned to MAPs (n = 85), SE (n = 81), or WLC (n = 81). MAPs and SE led to significant decreases in depressive symptoms from preintervention to postintervention relative to WLC (mean change relative to WLC [95% CI]: MAPs, -4.7 [-7.5 to -1.9]; SE, -4.0 [-6.9 to -1.1]), which persisted at 6-month follow-up for MAPs (mean change relative to WLC [95% CI]: MAPs, -3.7 [-6.6 to -0.8]; SE, -2.8 [-5.9 to 0.2]). MAPs, but not SE, also had beneficial effects on fatigue, insomnia, and vasomotor symptoms that persisted at 6-month follow-up ( < .05).
CONCLUSION
Mindfulness meditation and SE reduced depressive symptoms in younger breast cancer survivors. These interventions can be widely disseminated over virtual platforms and have significant potential benefit for quality of life and overall survivorship in this vulnerable group.
Topics: Adult; Breast Neoplasms; Cancer Survivors; Case-Control Studies; Depression; Fatigue; Female; Follow-Up Studies; Humans; Meditation; Middle Aged; Mindfulness; Quality of Life; Retrospective Studies; Sleep Initiation and Maintenance Disorders; Survivorship; Treatment Outcome; Young Adult
PubMed: 34406839
DOI: 10.1200/JCO.21.00279 -
Neuroscience Bulletin Jan 2020Insomnia is a common sleep disorder among older adults, and a risk factor for poor physical and mental health. However, the relationship between insomnia and cognitive... (Review)
Review
Insomnia is a common sleep disorder among older adults, and a risk factor for poor physical and mental health. However, the relationship between insomnia and cognitive health is not well understood. Here, we review observational studies that have investigated whether insomnia is associated with deficits in objective cognitive performance and an increased risk of dementia, magnetic resonance imaging studies that have assessed grey matter volumes and white matter microstructure, and interventional studies that have explored whether the treatment of insomnia can improve cognitive outcomes. There are inconsistent findings regarding impaired performance in objective cognitive tests and reduced grey matter volumes, and limited, emerging, evidence that suggests that insomnia is associated with an increased risk of dementia and reduced white matter integrity. Although the interventional literature is still in its infancy, there is some indication that treatment may have an impact on vigilance. Well-powered studies examining sources of heterogeneity are warranted.
Topics: Adult; Aged; Aged, 80 and over; Aging; Cognition; Cognitive Aging; Dementia; Female; Gray Matter; Humans; Male; Middle Aged; Neuropsychological Tests; Observational Studies as Topic; Risk Factors; Sleep; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; White Matter
PubMed: 31222500
DOI: 10.1007/s12264-019-00401-9 -
Menopause (New York, N.Y.) Apr 2020The Menopause Strategies: Finding Lasting Answers for Symptoms and Health clinical trials network was funded by the National Institutes of Health to find new ways to... (Review)
Review
OBJECTIVE
The Menopause Strategies: Finding Lasting Answers for Symptoms and Health clinical trials network was funded by the National Institutes of Health to find new ways to alleviate the most common, bothersome menopausal symptoms by designing and conducting multiple concurrent clinical intervention studies, accommodating a wide scope of populations and intervention strategies.
METHODS
Trials were conducted in Boston, Indianapolis, Minneapolis, Oakland, Philadelphia, and Seattle, with the Data Coordinating Center in Seattle, and were designed with standardized eligibility criteria and endpoints. Primary outcomes focused on vasomotor symptoms, sleep quality and insomnia symptoms, and vaginal symptoms. Secondary outcomes included quality of life, sexual function, and mood.
RESULTS
We completed five randomized clinical trials and three ancillary studies, testing nine interventions in over 1,300 women and collecting nearly 16,000 bio-specimens. Escitalopram, venlafaxine hydrochloride extended release, and low-dose estradiol diminished hot flashes by approximately 50% as compared with a 30% decrease by placebo. No benefits on vasomotor symptoms were observed with yoga or exercise compared with usual activity, nor with omega-3 supplementation compared with placebo. Cognitive behavioral therapy for insomnia reduced self-reported insomnia symptoms and improved overall sleep quality compared with menopause education control. We did not find significant benefit from a vaginal estradiol tablet or a vaginal moisturizer compared with placebo tablet and gel in diminishing the severity of vaginal symptoms.
CONCLUSIONS
The MsFLASH trials contributed substantially to our understanding of bothersome menopausal symptom treatment. It is important that clinicians counseling women about available treatment options consider all therapies-both nonhormonal and hormonal.
Topics: Aged; Female; Hot Flashes; Humans; Menopause; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic; Research Design; Sexual Dysfunction, Physiological; Sleep Initiation and Maintenance Disorders; Vaginal Diseases
PubMed: 31977667
DOI: 10.1097/GME.0000000000001461 -
Sensors (Basel, Switzerland) Jun 2024To investigate the activity-based prospective memory performance in patients with insomnia, divided, on the basis of actigraphic evaluation, into sleep onset,...
OBJECTIVE
To investigate the activity-based prospective memory performance in patients with insomnia, divided, on the basis of actigraphic evaluation, into sleep onset, maintenance, mixed and negative misperception insomnia.
METHODS
A total of 153 patients with insomnia (I, 83 females, mean age + SD = 41.37 + 16.19 years) and 121 healthy controls (HC, 78 females, mean age + SD = 36.99 + 14.91 years) wore an actigraph for one week. Insomnia was classified into sleep onset insomnia (SOI), maintenance insomnia (MaI), mixed insomnia (MixI) and negative misperception insomnia (NMI). To study their activity-based prospective memory performance, all the participants were required to push the actigraph event marker button twice, at bedtime (task 1) and at get-up time (task 2).
RESULTS
Only patients with maintenance and mixed insomnia had a significantly lower accuracy in the activity-based prospective memory task at get-up time compared with the healthy controls.
CONCLUSION
The results show that maintenance and mixed insomnia involve an impaired activity-based prospective memory performance, while sleep onset and negative misperception insomnia do not seem to be affected. This pattern of results suggests that the fragmentation of sleep may play a role in activity-based prospective memory efficiency at wake-up in the morning.
Topics: Humans; Female; Sleep Initiation and Maintenance Disorders; Male; Adult; Memory, Episodic; Middle Aged; Actigraphy; Sleep
PubMed: 38894403
DOI: 10.3390/s24113612 -
Clinical Therapeutics Apr 2022Sleep disturbance is common in primary care. The main treatment options include medication and cognitive behavioral therapy for insomnia. Best practice guidelines...
PURPOSE
Sleep disturbance is common in primary care. The main treatment options include medication and cognitive behavioral therapy for insomnia. Best practice guidelines recommend a collaborative decision-making approach to treatment. This study examined differences in insomnia treatment preferences based on demographic and clinical characteristics among primary care patients.
METHODS
A total of 200 patients (mean [SD] age, 54.92 [12.48] years) at a university medical center and community health clinic participated in brief screenings for insomnia, depression, anxiety, and insomnia treatment preference. Insomnia symptoms were measured with the Insomnia Severity Index, whereas depressive and anxiety symptoms were measured with the Patient Health Questionnaire 2 and Generalized Anxiety Disorder 2. χ analyses were performed to detect significant differences in preference between groups.
FINDINGS
A total of 46.5% of participants preferred medication and 56.0% preferred behavioral treatment (ratings not exclusionary). Preference for behavioral treatment was highest among severe insomnia presentations (15.2% preferred to 4.5% disliked; P = 0.002). Medication preference was higher among patients with elevated anxiety (57.3% preferred to 42.7% disliked; P = 0.017). Preference for behavioral treatment (66.7% preferred to 33.3% disliked; P = 0.012) and medication (56.8% preferred to 43.2% disliked; P = 0.016) was highest among those with elevated depression. Treatment preference only differed by age for behavioral treatment (P = 0.008). Preference was highest among patients ≤51 years of age (67.2% preferred to 32.8% disliked).
IMPLICATIONS
Primary care patients preferred behavioral and medication strategies for insomnia treatment. In addition, as mental health and sleep worsen, patients were more likely to prefer behavioral treatment. Knowledge of patient treatment preference may facilitate shared decision making, which increases patient satisfaction with care and engagement with treatment.
Topics: Anxiety; Cognitive Behavioral Therapy; Humans; Middle Aged; Primary Health Care; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Treatment Outcome
PubMed: 35361532
DOI: 10.1016/j.clinthera.2022.03.002 -
The Patient Mar 2021Chronic insomnia has major consequences for daytime functioning, yet no fully validated patient-reported outcome instrument for once-daily assessments is available to... (Observational Study)
Observational Study
BACKGROUND AND OBJECTIVE
Chronic insomnia has major consequences for daytime functioning, yet no fully validated patient-reported outcome instrument for once-daily assessments is available to measure these consequences. This study describes the development and psychometric evaluation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
METHODS
The Daytime Insomnia Symptom Scale (DISS), an existing 20-item instrument for assessing daytime functioning, was modified to give an 18-item version of the IDSIQ (IDSIQ-18) based on iterative qualitative interviews with 54 subjects with insomnia and expert input. The construct validity and other psychometric properties of the IDSIQ-18 were analyzed based on an interventional study (NCT03056053) in which subjects with insomnia received zolpidem (5 or 10 mg) daily for 2 weeks and an observational study among subjects with no diagnosis of insomnia (good sleepers). Participants in both studies completed the IDSIQ-18 daily for 2 weeks. Exit interviews were conducted with a sample of subjects who completed the interventional study to elicit concepts defining the experience of insomnia, to assess understanding of the response scales, and to determine meaningful change thresholds. Exploratory factor analysis and Rasch analysis were conducted to further assess the structure and latent model for the scoring of the final IDSIQ instrument. Further psychometric evaluation of the final IDSIQ was then conducted.
RESULTS
Subjects in both the interventional study (N = 114) and observational study (N = 103) were predominantly female (65% for subjects with insomnia and 60% for good sleepers). Mean age was 51 years for subjects with insomnia and 45 years for good sleepers. Subjects in the exit interviews (N = 41) demonstrated a good understanding of the IDSIQ-18 response scales. Day 1 mean scores were higher (worse) in subjects with insomnia compared with good sleepers. Based on inter-item correlation, exploratory factor, and Rasch analyses and review of the qualitative data, four items were removed. This yielded the final IDSIQ, with 14 items comprising three domains: Alert/Cognition, Mood, and Sleepiness. The domain structure was determined in a confirmatory factor analysis. Evidence of internal consistency reliability was strong: day 1 Cronbach's alpha was 0.917 for IDSIQ total score and 0.806-0.918 for the domains. Test-retest reliability, assessed for subjects with insomnia with no change on the Patient Global Assessment of Disease Severity scale between day 1 and day 8, was also good (intra-class correlation coefficient 0.856-0.911). Meaningful change thresholds derived for this sample using anchor-based approaches were 20 for IDSIQ total score, 9 for the Alert/Cognition domain, 4 for the Mood domain, and 4 for the Sleepiness domain.
CONCLUSIONS
These studies, which closely followed Food and Drug Administration Guidance for Industry on patient-reported outcome measures, support use of the IDSIQ as a fit-for-purpose measure for deriving valid and reliable endpoints in insomnia clinical research trials and real-world studies.
Topics: Female; Humans; Middle Aged; Patient Reported Outcome Measures; Psychometrics; Reproducibility of Results; Sleep Initiation and Maintenance Disorders; Surveys and Questionnaires
PubMed: 33131027
DOI: 10.1007/s40271-020-00474-z