Clinical Trial Search

Primary: Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks — -1.23; -1.58 Hours — p=0.510

Primary: Weekday Sleep Duration - Actigraphy — 6.309; 5.866; 5.880; 5.845 Number of hours — p=0.018

Primary: Impairment (Sheehan Disability Scale) — 14.30; 12.03; 11.76; 6.57 score on a scale — p=0.025

Primary: Dim Light Melatonin Onset (Hours) — 1.93; 0.80 hours

Primary: Oral Disposition Index — 11.5 None (Index) — p=.13

Primary: Bedtime — 7.44; 7.24; 22.98; 22.48 Hours

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

Primary: Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) — 11.56; 11.45; 9.52; 8.67 scores on a scale

Primary: Proportion of Patients Entrained as Assessed by Urinary aMT6 — 20; 2.6 percentage of patients

Primary: To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log…

Primary: Feasibility of Recruitment and Retention — 8; 6; 8; 6 participants

Primary: Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours. — 9; 8; 5 Participants

Primary: Subjective Total Sleep Time — 6.4; 7.0; 6.7; 6.7 hours — p=0.15

Primary: Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment — 20.72; 20.45; 23.05; 22.65 hours

Primary: Treatment Response (Phase 1) — 94 Participants

Primary: Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks — 6 logins per week

Primary: Total Sleep Time — 393; 420; 398; 409 units on a scale (minutes)

Primary: Sleep Disturbance — -1.9; -1.3 units on a scale

Primary: Provider Adherence to Sleep Specialist Recommendations — 4; 0; 8; 4 participants

Primary: Number of Participants With Adequate Data for Estimation of Dim Light Melatonin Onset (Self-Collected Saliva) — 7 Participants

Primary: Change in Pittsburgh Sleep Quality Index — -0.86; -3.15; -3.32 difference score of PSQI total

Primary: Change in Dim Light Melatonin Onset — 21.17; 20.77 decimal military time (hours) — p=0.2

Primary: Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment — 76.34; 77.64; 78.45; 76.38…

Primary: Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7) — 59.30; 39.40; 55.94; 55.12 minutes — p=0.646

Primary: Safety and Tolerability as Measured by Number of Participants With Adverse Events — 323 Participants

Primary: Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion — 4; 7; 5 Participants

Primary: Circadian Phase Shift — -0.48; 0.18; -1.14; -0.50 Hours

Primary: Sleep Efficiency — 89.1; 83.3 percent

Primary: Change in Average Total Sleep Time — 1.83; -0.33 hours/sleep opportunity — p=<0.05

Primary: Total Sleep Time (TST) — 51.03; 18.71 minutes — p==0.035