CompletedPhase 3

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

United States44 participantsStarted 2019-02-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet diagnostic criteria for delayed sleep wake phase disorder * Female participants of childbearing potential must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed. Exclusion Criteria: * Hypersensitivity to melatonin or any other component of the product * Sleep disorder other than delayed sleep wake phase disorder * Medical and psychiatric conditions that may influence sleep or be affected by melatonin * Current use of medications which may have interactions with melatonin * Pregnancy or breastfeeding * Routine night shift work * Past month travel or planned travel during the study across more than one time zone * Use of melatonin in the past month * Current use of medications that may interfere with the measurement of melatonin

What they're measuring

Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks

Timeframe: After 4 weeks of melatonin therapy

Trial details

NCT IDNCT03715465

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-05

Results submitted2022-10-31

View on ClinicalTrials.gov More Delayed Sleep Phase Syndrome trials