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NCT05293600 · ClinicalTrials.gov registry record · Phase 1
Rescue Pharmacotherapy for OSA
A Phase 1 study of Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT05293600: Recruiting Phase 1 study of Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital.
NCT05293600 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 70 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05293600, 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
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of undertreated OSA. In this study, the investigators want to test the addition of a drug treatment to their regimen. Endotypes will be targeted pharmacologically with one of the following drugs: acetazolamide for a high loop gain, atomoxetine-plus-eszopiclone for poor pharyngeal muscle compensation, or trazodone for a low arousal threshold. This aim is expected to provide treatment strategies for rescuing non-responders to MAD or HGNS therapy.
Primary Outcome
Based on previous studies the investigators anticipate that the interventional arm will reduce AHI through a positive effect on the abnormal endotype.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acetazolamide
- DRUG Trazodone
- DRUG Atomoxetine and eszopiclone
Study Locations (1)
Massachusetts
- Sleep Disorders Research Program Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 1 |
What NCT05293600 shows while recruiting
NCT05293600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05293600 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05293600 about?
NCT05293600 is a clinical study titled "Rescue Pharmacotherapy for OSA". Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of un...
What is the current status of trial NCT05293600?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2023-07-01. Estimated completion is 2026-10-30.
What conditions does trial NCT05293600 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT05293600?
The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG), Trazodone (DRUG), Atomoxetine and eszopiclone (DRUG).
Who is sponsoring clinical trial NCT05293600?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05293600 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05293600's enrollment target sits among peer trials
70 80th of 155 higher than 73 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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