Combined upper-airway electrical stimulation with a drug combo for sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled crossover trial in adults with obstructive sleep apnea who have a hypoglossal nerve stimulation (HGNS) device or are planned to receive one. Participants receive four treatment conditions in random order: HGNS plus AtoOxy, HGNS with placebo, AtoOxy alone (HGNS off), and placebo (HGNS off). The primary goal is to see if the combined treatment reduces breathing events during sleep more than HGNS alone. The study also explores whether each intervention helps compared with placebo and characterizes tolerability and safety of the therapies. The approach targets both mechanical airway support and pharmacologic modulation of airway muscles and arousal thresholds.

Why it matters

Who can join: the full rules

Inclusion Criteria for Enrolment:

* 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 Criteria:

* 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:

    1. "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?"
    2. "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)
  * 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

Where it's running

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

Study contacts

• Principal investigator: Scott A Sands, PhD — Brigham and Women's Hospital
• Study coordinator: Daniel P Vena, PhD
• Email: dvena@bwh.harvard.edu
• Phone: 617-852-0719

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tonsillectomy Added to Hypoglossal Nerve Stimulation for OSA with Lateral Wall Collapse

  In adults with obstructive sleep apnea and side-wide airway collapse, this study tests whether adding tonsil removal to hypoglossal nerve stimulation helps more than hypoglossal nerve stimulation alone.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07724938

• Understanding the genetics and immune response in PFAPA syndrome and tonsil disorders

  This study is trying to understand the genetics and immune responses in people with PFAPA syndrome and tonsil problems by collecting and analyzing blood and other samples.

  Recruiting at 2 sites National Institutes of Health Clinical Center (CC) · Washington D.C., District of Columbia and 2 other locations · NCT05656365

• Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography

  Researchers are testing a smart-mattress-based method that uses SpO2 and ballistocardiography data to predict sleep apnea severity in adults undergoing overnight sleep study.

  Recruiting Fu Jen Catholic University · New Taipei City, New Taipei City · NCT07923825

• Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

  This pilot test checks whether wearing a ring sensor at night and doing a 4-week at-home submental electrical stimulation is feasible for adults with obstructive sleep apnea and looks at changes in sleep metrics.

  Recruiting E-DA Hospital · Kaohsiung City · NCT07921329

• Functional capacity and muscle function in adults with obstructive sleep apnea

  This study tests how obstructive sleep apnea affects respiratory and peripheral muscle strength, endurance, and upper‑extremity function compared with healthy adults.

  Recruiting Karabuk University · Karabük · NCT07913139

• Transcutaneous Electrical Stimulation for Obstructive Sleep Apnea

  This study tests whether applying gentle electrical stimulation to the throat muscles at night can reduce sleep apnea severity in adults with obstructive sleep apnea.

  Recruiting Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07891702

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.