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CompletedNo phase

Feasibility of Upper Airway Stimulation in OSA

Key facts

Who runs it
Notos Medical Limited
Where
Belgium1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
17 people enrolled
Started
29 Jan 2026
Ended
27 Aug 2026
Type of study
Interventional
Treatments tested
  • Non-invasive electrical stimulation
Record updated
10 November 2026

Who can take part

Age
19 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any previous sleep-related driving accident
  • Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt
  • A diagnosis of periodic leg movement disorder
  • Unstable, untreated coronary or peripheral artery disease
  • Severe arterial hypertension defined as a resting blood pressure (BP) of >180/110mmHg
  • A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)
  • 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
  • Awake resting arterial oxygen saturation <93% (suggesting possible hypoventilation)
  • Currently employed as a professional driver

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • Non-invasive electrical stimulation of the upper airwayTreatment being tested

    Participants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy.

    Treatment: Non-invasive electrical stimulation

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
Record updated
10 November 2026