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NCT05944965 · ClinicalTrials.gov registry record · Phase 1
Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT05944965: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT05944965 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05944965, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Current therapies available for obstructive sleep apnea (OSA) have varying degrees of efficacy due to the complex nature of the disorder. A reduction in pharyngeal muscle activity characterizes OSA, and recent research has shown that combining atomoxetine and oxybutynin improves OSA severity. Thus this may be a viable treatment option. However, the specific effects of these agents alone and in combination on pharyngeal muscle activity remain unknown. The current study will look at the impact of each drug on pharyngeal muscles to gain insight into the mechanisms of this combination.
Primary Outcome
Peak genioglossus activity will be calculated as % of maximum activity (inspiratory peak of respiratory phase), and is referred to as "GGmin". Values estimated specifically for the first decile of ventilatory drive, i.e. when the pharyngeal airway is most vulnerable. This primary analysis will be unadjusted for ventilatory drive. Note that primary outcomes for genioglossus (Aim 1), tensor palatini (Aim 2), and ventilation (Aim 3) are treated as distinct physiological questions, each assessed us
Interventions
- DRUG Placebo
- DRUG Atomoxetine 80 MG
- DRUG Atomoxetine 80 mg plus Oxybutynin 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2025-06-17 |
| Phase | Phase 1 |
What the finished NCT05944965 record still lists
NCT05944965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05944965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05944965 about?
NCT05944965 is a clinical study titled "Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea". Current therapies available for obstructive sleep apnea (OSA) have varying degrees of efficacy due to the complex nature of the disorder. A reduction in pharyngeal muscle activity characterizes OSA, and recent research has shown that combining atomoxetine and oxybutynin improves OSA severity. Thus t...
What is the current status of trial NCT05944965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2023-12-01. Estimated completion is 2025-06-17.
What interventions are being tested in trial NCT05944965?
The interventions under investigation include: Placebo (DRUG), Atomoxetine 80 MG (DRUG), Atomoxetine 80 mg plus Oxybutynin 5 mg (DRUG).
Who is sponsoring clinical trial NCT05944965?
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 NCT05944965's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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