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

• Status: Active, not recruiting
• Trial end date: 2021-11-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Melatonin

Criteria

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