CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
Melatonin 0.5 MG +1 moredrug
Likely dose
Melatonin 0.5 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03715465
NCT03715465Phase 3Completed
CompareCT.gov

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

University of Michigan·interventional·Posted Oct 23, 2018·Updated Nov 25, 2022

In Brief

A Phase 3 clinical trial evaluating Melatonin 0.5 MG and Dim Light Melatonin Onset (salivary) for Delayed Sleep Phase Syndrome. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelayed Sleep Phase Syndrome
CountriesUnited States
CollaboratorsAmerican Academy of Sleep Medicine

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 23, 2018
Enrollment StartFeb 15, 2019
Primary CompletionNov 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.7 years ago

Interventions

Melatonin 0.5 MGdrug

Melatonin tablet

Dim Light Melatonin Onset (salivary)other

Test to determine the time of melatonin onset in saliva under dim light conditions