Phase 3 N=320 Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Jet Lag Type Insomnia
Primary: Total Sleep Time in the First Two Thirds of the Night — 156.1; 216.4 Minutes — p=<.0001
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=25 A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Jet Lag Disorder
Primary: Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted — 76.2; 41.4 minutes — p=0.0354
N/A N=15 Blue Blockers at Night and Insomnia Symptoms
Insomnia · Sleep
Primary: Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score — 72.64 units on a scale
Phase 4 N=79 Treatment of Insomnia in Migraineurs
Insomnia · Migraine
Primary: Total Sleep Time — 5.4; 5.5; 6.3; 6.1 hours — p=0.33
N/A N=6 Cognitive Behavioral Therapy and Light Therapy
Pulmonary Hypertension · Insomnia · Fatigue
Primary: Retention Rate — 0; 1; 2 Participants
N/A N=154 Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Menopause
Primary: Diary Based Sleepiness — 5.01; 5.13; 4.87; 4.72 score on a scale
N/A N=28 The Psychoneuroimmunology of Insomnia
Primary Insomnia
Primary: Positive Antibody Response — 7; 7 participants
N/A N=20 Sleep Loss and Mechanisms of Impaired Glucose Metabolism
Primary Insomnia
Primary: Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test — .33; -0.10 %/min, slope of natural log glucose
N/A N=211 Sequenced Therapies for Comorbid and Primary Insomnias
Insomnia Comorbid to Psychiatric Disorder · Primary Insomnia
Primary: Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index — 40.00; 34.94; 37.04; 48.15 percent remitted
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
Phase 3 N=427 Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Excessive Sleepiness
Primary: Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 — 7.7; 11.7; 4.8 Minutes — p=<0.0001
N/A N=56 Insomnia Treatment and Problems (the iTAP Study)
Insomnia · Alcohol; Harmful Use
Primary: Insomnia Severity — 6.86; 10.84; 6.58; 9.32 units on scale, Insomnia Severity Index
Phase 2 N=42 Effectiveness of BBT-I and Zopiclone for Chronic Insomnia
Insomnia Chronic
Primary: Insomnia Severity Index — 18.6; 18.9; 13.1; 14.0 units on a scale
Phase 2 N=39 Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia
Short-term Insomnia
Primary: Total Sleep Time — 382.9; 339.2; 256.2 minutes
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
Phase 4 N=69 Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
Sleep Disorders
Primary: Change in Pittsburgh Sleep Quality Index — -0.86; -3.15; -3.32 difference score of PSQI total
N/A N=149 Insomnia Treatment for Women Veterans
Insomnia
Primary: Number of Participants Completing 5 Behavioral Treatment Sessions — 63; 70 Participants — p==.120
N/A N=45 A High Density EEG Comparison of Sleep Patterns in Insomnia
Primary Insomnia
Primary: EEG Power During Sleep — 1.40; 1.17 μV^2/Hz — p=0.2791
Phase 2 N=118 Internet-based Treatment for Chronic Insomnia
Insomnia · Insomnia Disorder
Primary: Sleep Quality — 1.77; 2.18 0-4 scale of sleep quality
Phase 3 N=30 Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Chronic Insomnia · Primary Insomnia
Primary: Pittsburgh Sleep Quality Index (PSQI) — 7.7; 9.2; 7.0; 8.2 units on a scale
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
Phase 4 N=41 Suvorexant and Trauma Related Insomnia
Insomnia · Posttraumatic Stress Disorder
Primary: Change in Insomnia Severity Index Score From Baseline. — 6.8; 8.6 units on a scale — p=<.05
Phase 3 N=126 Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Insomnia · End Stage Renal Disease
Primary: Insomnia Severity Index (ISI) Short-term — 12.47; 11.97; 13.05 score on a scale — p=0.6761
Phase 1 N=24 A Study of LY2624803 in Japanese Participants With Transient Insomnia
Sleep Initiation and Maintenance Disorders
Primary: Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo — 58.88; 40.70; 32.27; 18.42 minutes (min) — p=0.908
N/A N=189 Insomnia Self-Management in Heart Failure
Cardiac Failure · Heart Failure · Congestive Heart Failure
Primary: Change in Insomnia Severity — -6.60; -3.46 score on a scale — p=0.0002
N/A N=32 Metabolomics of Insomnia-Related Hyperarousal
Primary Insomnia
Primary: Number of Metabolites Elevated Relative to the Other Group. — 13; 9 Number of metabolites elevated
N/A N=16 Sleep Length and Circadian Regulation in Humans
Sleep Disorders
Primary: Dim Light Melatonin Onset (Hours) — 1.93; 0.80 hours
N/A N=21 Reduce Emotional Symptoms of Insomnia With SleepTreatment
Insomnia · Rumination
Primary: Insomnia Severity Index — 16.42; 8.37; 11.72 score on a scale
Phase 3 N=72 A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Primary Insomnia
Primary: Latency To Persistent Sleep (LPS) — 37.5; 24.4; 20.9; 12.8 Minutes
Phase 2 N=27 Effects of Melatonin on Insomnia Symptoms in Older Adults
Sleep Initiation and Maintenance Disorders
Primary: Peak Melatonin Level — 405; 3999; 52 pg/ml — p=<0.001