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NCT03796026 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT03796026: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT03796026 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03796026, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.
Primary Outcome
AHI score is used to indicate the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as: Normal: AHI less than (\<)5, Mild sleep apnea: 5 less than or equal to (\<=) AHI \<15, Moderate sleep apnea: 15\<= AHI \<30, and Severe sleep apnea: AHI greater than or equal to (\>=)30.
Interventions
- DRUG Placebo
- DRUG Seltorexant 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-01-04 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 1 |
What the finished NCT03796026 record still lists
NCT03796026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03796026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03796026 about?
NCT03796026 is a clinical study titled "A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea". The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.
What is the current status of trial NCT03796026?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-01-04. Estimated completion is 2019-06-14.
What interventions are being tested in trial NCT03796026?
The interventions under investigation include: Placebo (DRUG), Seltorexant 40 mg (DRUG).
Who is sponsoring clinical trial NCT03796026?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03796026's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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