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

Delayed Sleep Phase Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03715465
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase Phase 3
Start date February 15, 2019
Completion date November 5, 2021
View Details
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