Upper airway electrical stimulation for obstructive sleep apnea
Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
This pilot tries a 5-month course of non-invasive upper airway electrical stimulation to see if it is safe and tolerable for adults with moderate obstructive sleep apnea (AHI 15–50).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Notos Medical Limited Industry-sponsored |
| Locations | 1 site (Edegem) |
| Trial ID | NCT07396649 on ClinicalTrials.gov |
What this trial studies
Project Breathe 1 is an unblinded, uncontrolled single-arm 5-month pilot that delivers non-invasive electrical stimulation to the upper airway in adults with moderate obstructive sleep apnea to observe safety and tolerability. Eligible participants have a baseline polysomnography with AHI 15–50, BMI under 32 kg/m², are over 18 years old, and can read and speak Dutch. After screening and baseline PSG, enrolled participants receive the stimulation device and are followed with scheduled safety monitoring and sleep studies during the study period. The trial is designed to document short-term adverse events and participant tolerability rather than to provide definitive efficacy data.
Who should consider this trial
Good fit: Adults over 18 with moderate OSA (AHI 15–50) and BMI <32 kg/m² who can undergo baseline and follow-up polysomnography, speak Dutch, and attend visits at the study site are ideal candidates.
Not a fit: Patients with primarily central sleep apnea, BMI ≥32, implanted cardiac devices, inability to sleep supine, pregnancy, severe cardiovascular disease, periodic limb movement disorder, or other listed exclusions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a non-invasive alternative to reduce obstructive events and improve sleep for some adults who cannot tolerate CPAP or prefer to avoid implanted devices.
How similar studies have performed: Implanted hypoglossal nerve stimulation devices have shown benefit in selected patients, but non-invasive upper airway electrical stimulation is a relatively novel approach with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Obstructive sleep apnoea diagnosis with an AHI of 15-50 events/hour recorded in the baseline polysomnography (PSG) * BMI \< 32 kg/m² * Age \> 18 years old * Able to read, write, and speak Dutch with acceptable visual and auditory acuity * Able and willing to provide informed consent Exclusion Criteria: * Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt * Central (non-obstructive) AHI episodes \>5 events/hour recorded in the baseline PSG * Inability to sleep supine * Pregnancy * Inability to undergo DISE * Inability or unwillingness to shave under and around their chin and neck if appropriate * Known inability to complete PSG with a total sleep time of \> 4 hours * The use of other neurostimulatory devices * A diagnosis of periodic leg movement disorder * Awake resting arterial oxygen saturation \<93% (suggesting possible hypoventilation) * Unstable, untreated coronary or peripheral artery disease * Severe arterial hypertension defined as a resting blood pressure (BP) of \>180/110mmHg * Currently employed as a professional driver * Any previous sleep-related driving accident * A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)
Where this trial is running
Edegem
- Antwerp University Hospital — Edegem, Belgium (Recruiting)
Study contacts
- Principal investigator: Johan Verbraecken — Universiteit Antwerpen
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.