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

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea, Sleep-disordered Breathing

In brief

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.

Key facts

Study ID

NCT07577661

Run by

Brigham and Women's Hospital

People needed

24

Starts

2026-06-01

Expected to finish

2027-12-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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:
• chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
• 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:
• "During the last month, when urinating, have you had the sensation of not emptying your bladder completely more often than 1 out of 5 times?"
• "During the last month, have you had a weak urinary stream more often than 1 out of 5 times?
• 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)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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