Phase 4 N=29 Lemborexant Shift Work Treatment Study
Shift-Work Related Sleep Disturbance
Primary: Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary — 362.7; 365.3 Minutes per day — p=0.884
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=24 Effects of Daytime Eszopiclone Administration in Shift Workers
Shift-Work Sleep Disorder
Primary: Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests — 11.0; 14.75 minutes
Phase 3 N=254 Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
Excessive Sleepiness · Shift Work Sleep Disorder
Primary: Multiple Sleep Latency Test (MSLT) — 3.1; 0.4 Minutes — p=<0.0001
N/A N=16 Sleep Length and Circadian Regulation in Humans
Sleep Disorders
Primary: Dim Light Melatonin Onset (Hours) — 1.93; 0.80 hours
Phase 4 N=19 Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Sleep Disorder, Shift-Work
Primary: Change in Average Total Sleep Time — 1.83; -0.33 hours/sleep opportunity — p=<0.05
Phase 4 N=383 Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
Excessive Sleepiness
Primary: Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at…
N/A N=1,189 Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Shift-Work Sleep Disorder · Insomnia · Restless Leg Syndrome
Primary: Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months — 3.1; 3.2; 1.4; 2.6 days/firefighter — p=0.66
Phase 3 N=328 Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Narcolepsy · Sleep Apnea, Obstructive · Sleep Apnea Syndromes
Primary: Safety and Tolerability as Measured by Number of Participants With Adverse Events — 323 Participants
N/A N=19 The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Sleep Disturbance · Insomnia · Acute Coronary Syndrome
Primary: Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion — 4; 7; 5 Participants
Phase 3 N=40 The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Delayed Sleep Phase Syndrome
Primary: Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks — -1.23; -1.58 Hours — p=0.510
N/A N=121 A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
Mental Disorders
Primary: Impairment (Sheehan Disability Scale) — 14.30; 12.03; 11.76; 6.57 score on a scale — p=0.025
N/A N=11 Ramelteon for a Nap Prior to a Night Shift
Healthy
Primary: Sleep Efficiency — 89.1; 83.3 percent
Early Phase 1 N=30 Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation
Renal Disease · Sleep Disorders
Primary: Bedtime — 7.44; 7.24; 22.98; 22.48 Hours
N/A N=12 Influence of Nocturnal Light Exposure on the Impairment of Glucose Tolerance Induced by Chronic Sleep Restriction
Glucose Intolerance · Sleep Deprivation · Sleep
Primary: Impairment of Insulin Sensitivity — -0.80; 0.55 (mU/L)^-1 min^-1
N/A N=120 Home Sleep and Circadian Phase: Mediators of Diabetes Risk
Sleep Deprivation · Diabetes · Circadian Dysregulation
Primary: Oral Disposition Index — 11.5 None (Index) — p=.13
N/A N=142 Delayed Sleep Timing in Teens Study
Delayed Sleep Phase
Primary: Weekday Sleep Duration - Actigraphy — 6.309; 5.866; 5.880; 5.845 Number of hours — p=0.018
N/A N=10 Circadian Rhythm Disruption Effects on Smoke Inhalation
Inflammation · Sleep Deprivation · Circadian Rhythm Sleep Disorder, Shift Work Type
Primary: Blood Inflammation — 0.69; 0.79; 2.33; 1.63 pg/mL — p=<0.05
N/A N=34 Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
Delayed Sleep-Wake Phase Disorder
Primary: Change in School Night Sleep Onset Time — 0.4; 0.6 hours
N/A N=44 Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
Sleep Phase Rhythm Disturbance · Sleep Deprivation
Primary: 17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator) — 8.66; 10.46 units on a scale
N/A N=15 Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Primary: Feasibility of Recruitment and Retention — 8; 6; 8; 6 participants
Phase 3 N=84 Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Non-24-Hour Sleep-Wake Disorder
Primary: Proportion of Patients Entrained as Assessed by Urinary aMT6 — 20; 2.6 percentage of patients
N/A N=30 Chronic Insomnia and CSF Markers of Dementia
Insomnia Chronic
Primary: CSF Markers Related to Dementia — 4332.1; 4824.0; 393.2; 419.4 picograms per milliliter
N/A N=19 The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis
Ulcerative Colitis
Primary: Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment — 20.72; 20.45; 23.05; 22.65 hours
N/A N=44 P20 Extending Sleep to Reverse Metabolic Syndrome
Metabolic Syndrome
Primary: SASI Acceptability Questionnaire Score at Pre-Intervention — 3.91 score on a scale
Phase 4 N=115 Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
Insomnia · Insomnia Chronic
Primary: Treatment Response (Phase 1) — 94 Participants
N/A N=452 Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
Blood Pressure · Depression
Primary: Sleep Per 24 Hours — 5.61; 5.81; 5.99; 6.23 Hours of sleep/24 hours
Phase 4 N=67 Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Type 2 Diabetes Mellitus · Insomnia · Sleep Disorder
Primary: Subjective Total Sleep Time — 6.4; 7.0; 6.7; 6.7 hours — p=0.15
N/A N=118 Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Sleep Initiation and Maintenance Disorders
Primary: Total Sleep Time — 393; 420; 398; 409 units on a scale (minutes)
N/A N=25 RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
Alcohol Use Disorder · Alcohol Dependence · Insomnia
Primary: Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks — 6 logins per week
Phase 2 N=68 Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Depression
Primary: Hamilton Rating Scale for Depression-17 Item Minus Sleep Items — 6.1; 8.1; 6.3 units on a scale — p=.202