Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea (NCT07577661)
Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea: A Randomized-Controlled Trial.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Brigham and Women's Hospital — Boston, Massachusetts
Age range: 18 Years to 79 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Brigham and Women's Hospital — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (617) 852-0719
Email: dvena@bwh.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Obstructive Sleep Apnea
- RPMO2 Oximeter Accuracy During Sleep 1 Trial — Dallas, Texas
- Validation of Sleep Questionnaires in the Down Syndrome Population — Portland, Oregon
- 3D Printer Modified CPAP Mask for Obstructive Sleep Apnea — Boston, Massachusetts
- Breathing Training for Improving Cardiovascular Health in Older Adults With Sleep Apnea — Tucson, Arizona
- Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation — Memphis, Tennessee
- Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC) — New York, New York
Explore by condition: All Obstructive Sleep Apnea clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.