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NCT04014387 · ClinicalTrials.gov registry record · Phase 4
Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT04014387: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT04014387 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04014387, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
Prior research has identified profound sleep disruption in individuals with PSP. Not only were these individuals sleeping relatively short periods at night, they were also not recuperating lost sleep during the day. Research also showed the relative preservation of a series of nuclei key in regulating wake and arousal. Investigators believe that therapeutically targeting wake promoting centers with a specific medication will improve sleep quality and overall well-being in PSP. To study this, investigators will be doing a double blind, within subject, remote clinical trial with 3 conditions: suvorexant- which targets a wake promoting system, zolpidem- a standard hypnotic that engages sleep promoting systems, versus placebo. Each condition will last 1 week and will be separated by a 1 week washout period on no sleep medications. Investigators will measure sleep patterns and daytime symptoms to determine if suvorexant, zolpidem, or both medications are safe and effective for treating sleep disturbances and improving overall well-being in PSP.
Primary Outcome
Change in sleep efficiency (as measured by actigraphy), this is a percentage of the time spent asleep compared to the total time in bed. The range of scores is 0-100, with higher scores associated with better sleep efficiency.
Interventions
- DRUG Placebo oral capsule
- DRUG Suvorexant
- DRUG Zolpidem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-06-02 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 4 |
What the finished NCT04014387 record still lists
NCT04014387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT04014387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04014387 about?
NCT04014387 is a clinical study titled "Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)". Prior research has identified profound sleep disruption in individuals with PSP. Not only were these individuals sleeping relatively short periods at night, they were also not recuperating lost sleep during the day. Research also showed the relative preservation of a series of nuclei key in regulati...
What is the current status of trial NCT04014387?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2019-06-02. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT04014387?
The interventions under investigation include: Placebo oral capsule (DRUG), Suvorexant (DRUG), Zolpidem (DRUG).
Who is sponsoring clinical trial NCT04014387?
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 NCT04014387's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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