NCT03715465

The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder

The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether measuring the circadian clock during treatment of delayed sleep-wake phase disorder results in greater improvements in sleep compared to estimating the circadian clock.

Detailed description

The study is a randomized, controlled, parallel double-blind 4-week trial of 0.5 mgs of exogenous melatonin timed to either 3 h before actual dim light melatonin onset (DLMO) based on in-home measurement (M-DLMO, n = 25) or 3 h before DLMO estimated at 2 h before average sleep onset time based on actigraphy and sleep diary (E-DLMO, n = 25) in adult participants with delayed sleep-wake phase disorder. All participants will receive melatonin 0.5 mgs. Outcomes include change in DLMO, subjective and objective sleep parameters, and daytime symptoms. As of January 7, 2020, the Insomnia Severity Index was removed from the IRB-approved protocol. No data were collected for this measure.

Conditions

• Delayed Sleep Phase Syndrome

Interventions

Type	Name	Description
DRUG	Melatonin 0.5 MG	Melatonin tablet
OTHER	Dim Light Melatonin Onset (salivary)	Test to determine the time of melatonin onset in saliva under dim light conditions

Timeline

• Start date: 2019-02-15
• Primary completion: 2021-11-05
• Completion: 2021-11-05
• First posted: 2018-10-23
• Last updated: 2022-11-25
• Results posted: 2022-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study