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NCT05350215 · ClinicalTrials.gov registry record · Phase 1
Atomoxetine and DAW2022 on OSA Severity
A Phase 1 study of Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05350215: Recruiting Phase 1 study of Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital.
NCT05350215 is a Phase 1 study of Obstructive Sleep Apnea that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 18 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05350215, a Phase 1 study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine.
Primary Outcome
OSA severity will be quantified by the number of respiratory events/h (AHI)
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Atomoxetine Oral Capsule [Strattera]
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
What NCT05350215 shows while recruiting
NCT05350215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT05350215 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05350215 about?
NCT05350215 is a clinical study titled "Atomoxetine and DAW2022 on OSA Severity". Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxyb...
What is the current status of trial NCT05350215?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-06-01. Estimated completion is 2026-06-01.
What conditions does trial NCT05350215 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT05350215?
The interventions under investigation include: Placebo oral capsule (DRUG), Atomoxetine Oral Capsule [Strattera] (DRUG).
Who is sponsoring clinical trial NCT05350215?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05350215 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05350215's enrollment target sits among peer trials
18 144th of 155 higher than 9 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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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