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NCT03715465 · ClinicalTrials.gov registry record · Phase 3
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
A Phase 3 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT03715465: Completed Phase 3 study, sponsored by University of Michigan.
NCT03715465 is a Phase 3 study that has completed, run by University of Michigan. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03715465, a Phase 3 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study 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.
Primary Outcome
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.
Interventions
- DRUG Melatonin 0.5 MG
- OTHER Dim Light Melatonin Onset (salivary)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-02-15 |
| Est. Completion | 2021-11-05 |
| Phase | Phase 3 |
What the finished NCT03715465 record still lists
NCT03715465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Melatonin 0.5 MG is the first listed.
NCT03715465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03715465 about?
NCT03715465 is a clinical study titled "The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder". 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.
What is the current status of trial NCT03715465?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2019-02-15. Estimated completion is 2021-11-05.
What interventions are being tested in trial NCT03715465?
The interventions under investigation include: Melatonin 0.5 MG (DRUG), Dim Light Melatonin Onset (salivary) (OTHER).
Who is sponsoring clinical trial NCT03715465?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03715465's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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