Actively Recruiting
Feasibility of Upper Airway Stimulation in OSA
Led by Notos Medical Limited · Updated on 2026-02-09
15
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Project Breathe 1 is a short-duration (5 month) pilot investigation to assess the safety and tolerability of non-invasive electrical stimulation in adults with obstructive sleep apnoea. The investigation is an unblinded, uncontrolled, single arm design.
CONDITIONS
Official Title
Feasibility of Upper Airway Stimulation in OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with obstructive sleep apnea with an apnea-hypopnea index (AHI) of 15-50 events per hour based on baseline polysomnography
- Body mass index (BMI) less than 32 kg/m²
- Age older than 18 years
- Able to read, write, and speak Dutch with acceptable vision and hearing
- Able and willing to provide informed consent
You will not qualify if you...
- Having a cardiac pacemaker, implantable cardiac defibrillator, or ventriculoperitoneal shunt
- Central (non-obstructive) AHI episodes greater than 5 events per hour on baseline polysomnography
- Unable to sleep lying on the back (supine)
- Pregnant
- Unable to undergo drug-induced sleep endoscopy (DISE)
- Unable or unwilling to shave under and around the chin and neck if needed
- Unable to complete polysomnography with total sleep time over 4 hours
- Using other neurostimulation devices
- Diagnosed with periodic leg movement disorder
- Awake resting arterial oxygen saturation below 93%
- Have unstable or untreated coronary or peripheral artery disease
- Have severe high blood pressure (resting BP over 180/110 mmHg)
- Currently working as a professional driver
- History of sleep-related driving accidents
- Any past or current condition that the investigator believes contraindicates participation (such as chronic substance abuse or severe psychiatric disorders)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Antwerp University Hospital
Edegem, Belgium, 2650
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here