Back to search results

Combination Therapy for Obstructive Sleep Apnea with Hypoglossal Nerve Stimulation and Atomoxetine-Oxybutynin

This study is looking at new ways to treat Obstructive Sleep Apnea (OSA), a condition where your breathing repeatedly stops and starts during sleep. It's testing if combining an implanted device called hypoglossal nerve stimulation (HGNS, Inspire Medical) with two oral medications, atomoxetine and oxybutynin (AtoOxy), can improve breathing more than either treatment alone. HGNS works by stimulating a nerve to keep your airway open. AtoOxy is being studied because it may also help keep your airway open and improve other factors related to OSA. The study will measure how much your Apnea-Hypopnea Index (a measure of OSA severity) changes after 2 weeks of treatment. You may be able to join if you are 18-79 years old, have OSA, and already have an Inspire device or are scheduled to get one. The study status is currently unclear.

Study design
This is a randomized, placebo-controlled, crossover study with 24 participants. It compares four different treatment conditions: HGNS with AtoOxy, HGNS alone (with a placebo pill), AtoOxy alone (with the HGNS device off), and a placebo (with the HGNS device off).
What's involved
You would need to be willing to turn off your HGNS device for up to 6 weeks while testing different therapies. The study will assess the effects of treatments over 2 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Apnea-Hypopnea Index, is measured at 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07577661

Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea

Not Yet Recruiting
PHASE1Ages 18–79InterventionalTreatment
Brigham and Women's Hospital
~24 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy)Unilateral hypoglossal nerve stimulation (HGNS), active comparator conditionAtomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator conditionPlacebo; placebo comparator condition

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apnea-Hypopnea Index
Measured over 2 Weeks

Conditions

Obstructive Sleep Apnea
Sleep-disordered Breathing

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Scott A Sands, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Daniel P Vena, PhD
[email protected]
617-852-0719
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Ages 18 - 79 years
Diagnosed OSA
Implantation of a hypoglossal nerve stimulation device (HGNS, Inspire Medical) or scheduled for implantation (implantation required for randomization)
Willingness to withhold HGNS while testing therapies (up to 6 weeks with HGNS off \[with/without pharmacotherapy\] to assess benefits of HGNS therapy).

Exclusion

Any uncontrolled medical condition
Current use of the medications under investigation.
Issues relating to short-term withdrawal of HGNS therapy
Excluded: Occupational driving (truck drivers, fork-lift operation, taxi/uber drivers)
Excluded: History of traffic accidents attributable to sleepiness or fatigue (\<2 years).
Use of SNRIs/SSRIs or anticholinergic medications during the study.
Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
Respiratory disorders other than sleep disordered breathing:
Other sleep disorders: narcolepsy, parasomnias. Insomnia
Contraindications for atomoxetine and oxybutynin, including:
hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria)
pheochromocytoma
use of monoamine oxidase inhibitors
diagnosed benign prostatic hypertrophy, urinary retention
suspected benign prostatic hypertrophy / urinary retention based on a positive answer to either of the following questions:
known untreated narrow angle glaucoma
known bipolar disorder, mania, psychosis
known history of major depressive disorder (age\<24).
known history of attempted suicide or suicidal ideation within one year prior to screening
known clinically significant constipation, gastric retention
known pre-existing seizure disorders
known clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2)
known clinically-significant liver disorders
known clinically-significant cardiovascular conditions
moderate-to-severe hypertension (SBP\>160 mmHg or DBP\>100 mmHg measured at baseline; average of evening and morning measures)
known cardiomyopathy (LVEF\<50%) or heart failure
known advanced atherosclerosis
recent cerebrovascular events (within 2 years)
recent history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation (within 2 years)
other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
myasthenia gravis
pregnancy/breast-feeding

What this trial measures

  • Apnea-Hypopnea Index2 Weeks

    Apnea-hypopnea index (AHI), defined as the number of apneas and hypopneas per hour of sleep, measured by overnight polysomnography at the end of each treatment period. Quantitative outcome variable: percent change (symmetrized) from baseline.