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NCT02908529 · ClinicalTrials.gov registry record · Phase 1
Atomoxetine and Oxybutynin in Obstructive Sleep Apnea
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02908529: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT02908529 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02908529, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug) administered together on OSA phenotype traits and OSA severity during sleep.
Primary Outcome
Based on previous studies the investigators anticipate that Atomoxetine and Oxybutynin will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI\<32), Vpassive \> 50% of Veupnea (ventilation during eupneic ventilatory drive), low muscle compensation (Vactive - Vpassive \<1 L/min)
Interventions
- DRUG Combination product of Atomoxetine and Oxybutynin
- DRUG Placebo, 2 tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-09 |
| Est. Completion | 2018-01 |
| Phase | Phase 1 |
What the finished NCT02908529 record still lists
NCT02908529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Combination product of Atomoxetine and Oxybutynin is the first listed.
NCT02908529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02908529 about?
NCT02908529 is a clinical study titled "Atomoxetine and Oxybutynin in Obstructive Sleep Apnea". Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. Until...
What is the current status of trial NCT02908529?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2016-09. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02908529?
The interventions under investigation include: Combination product of Atomoxetine and Oxybutynin (DRUG), Placebo, 2 tablets (DRUG).
Who is sponsoring clinical trial NCT02908529?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02908529's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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