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NCT06091085 · ClinicalTrials.gov registry record · Phase 1
Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA
A Phase 1 study of OSA, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06091085: Recruiting Phase 1 study of OSA, sponsored by Brigham and Women's Hospital.
NCT06091085 is a Phase 1 study of OSA that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 36 participants, below the 163-participant average among 14 other OSA trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06091085, a Phase 1 study of OSA, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a "classic" model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. This drive-dependent OSA is due to ventilation instability that occurs during respiratory events however these individuals have spontaneous increases in drive during respiratory events that stabilize their airway (i.e., via improving upper airway muscle activity) and reduce the risk of respiratory events in people with OSA. Therefore, by stabilizing the ventilatory drive, OSA should be treatable. Acetazolamide is a pharmacological ventilatory stimulant and has been previously shown to reduce OSA severity. As such in this study, the goal is to demonstrate acetazolamide improves OSA severity in 'drive-dependent' OSA people by improving drive-related pharyngeal obstructions compared to the 'classic' OSA people.
Primary Outcome
The primary efficacy outcome measure is the apnea hypopnea index (3% desaturation or arousal), presented as a percent reduction from baseline. Differences in this measure with active versus placebo therapy will be assessed. The primary comparison will be the difference in this measure in drive-dependent versus classic OSA subgroups.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acetazolamide
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06091085 shows while recruiting
NCT06091085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 163-participant average among 14 other OSA trials with a reported enrollment target (78% lower).
The record links to 1 condition, with OSA appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06091085 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06091085 about?
NCT06091085 is a clinical study titled "Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA". Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a "classic" model of OSA has been used to describe the disorder, which fails to ...
What is the current status of trial NCT06091085?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-01-31. Estimated completion is 2027-12-31.
What conditions does trial NCT06091085 study?
This clinical trial studies the following conditions: OSA.
What interventions are being tested in trial NCT06091085?
The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG).
Who is sponsoring clinical trial NCT06091085?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06091085 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
Similar trials for OSA
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 NCT06091085's enrollment target sits among peer trials
36 8th of 14 higher than 5 of 14 other OSA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other OSA 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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