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NCT07577661 · ClinicalTrials.gov registry record · Phase 1
Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT07577661 is a Phase 1 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 24 participants.
The verdict
NCT07577661, a Phase 1 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is a common condition in which the airway repeatedly collapses during sleep, leading to poor sleep quality and reduced oxygen levels. Hypoglossal nerve stimulation (HGNS) is an approved treatment that uses a small implanted device to stimulate the genioglossus muscle and keep the airway open. However, some patients continue to have OSA despite using HGNS. Atomoxetine and oxybutynin, "AtoOxy", is a promising pharmacologcal therapy under investigation that has been shown to activate pharyngeal muscles-in particular non-genioglossus muscles--but appears more efficacious in some patients than others. This study will test whether the combination of AtoOxy and HGNS can further improve breathing during sleep compared to either monotherapy alone. Participants with OSA and an HGNS device will be randomized to receive, in random order: HGNS+AtoOxy, HGNS alone (plus placebo), AtoOxy alone (HGNS device off), and placebo (HGNS device off), in a cross-over trial. The main goal is to determine whether the combined treatment reduces the number of breathing events during sleep; the primary outcome test will compare HGNS+AtoOxy versus HGNS alone. The effect of each intervention versus placebo will also be presented. The study will also examine how individual patient characteristics influence response to treatment.
Interventions
- OTHER Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy)
- DEVICE Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition
- DRUG Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition
- DRUG Placebo; placebo comparator condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07577661
The ClinicalTrials.gov registry entry for NCT07577661 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy) is the first listed.
NCT07577661 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07577661 about?
NCT07577661 is a clinical study titled "Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea". Obstructive sleep apnea (OSA) is a common condition in which the airway repeatedly collapses during sleep, leading to poor sleep quality and reduced oxygen levels. Hypoglossal nerve stimulation (HGNS) is an approved treatment that uses a small implanted device to stimulate the genioglossus muscle an...
What is the current status of trial NCT07577661?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2026-06-01. Estimated completion is 2027-12-01.
What interventions are being tested in trial NCT07577661?
The interventions under investigation include: Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy) (OTHER), Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition (DEVICE), Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition (DRUG), Placebo; placebo comparator condition (DRUG).
Who is sponsoring clinical trial NCT07577661?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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