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NCT05344443 · ClinicalTrials.gov registry record · Phase 4
Lemborexant Shift Work Treatment Study
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT05344443: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT05344443 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05344443, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
Primary Outcome
Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was recorded using the Consensus Sleep Diary, which participants completed daily.
Interventions
- DRUG Placebo
- DRUG Lemborexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2024-11-30 |
| Phase | Phase 4 |
What the finished NCT05344443 record still lists
NCT05344443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05344443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05344443 about?
NCT05344443 is a clinical study titled "Lemborexant Shift Work Treatment Study". Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which woul...
What is the current status of trial NCT05344443?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2022-03-10. Estimated completion is 2024-11-30.
What interventions are being tested in trial NCT05344443?
The interventions under investigation include: Placebo (DRUG), Lemborexant (DRUG).
Who is sponsoring clinical trial NCT05344443?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05344443's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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