Feasibility of Upper Airway Stimulation in OSA
Obstructive Sleep Apnoea (OSA)
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 19 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 17 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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)
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Non-invasive electrical stimulation of the upper airway
Participants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy.
Device: Non-invasive electrical stimulation
Non-invasive electrical stimulation DEVICE
The non-invasive electrical stimulation components will consist of two Digitimer DS5 isolated current stimulators, voltage control by an NI-9262 module, and two pairs of adhesive electrodes placed in the submandibular region.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Tolerability of non-invasive electrical stimulation of the upper airway during sleep
Time frame: Night 1
The proportion of participants who are able to tolerate 80% of their maximum awake tolerated dose during sleep.
Secondary measures
Arousals
Time frame: Night 1
Number of arousals during sleep when patient is undergoing non-invasive electrical stimulation of the upper airway during respiratory events.
Subjective awareness of stimulation during sleep
Time frame: Night 1
Number of actual stimulation events compared to number of events felt by the participant. Number of subjective events will be determined post-sleep.
Other measures
Respiratory disturbance index
Time frame: Baseline, Night 1
Number of arousals from respiratory events. Only arousals during which stimulation was initiated will be included.
Apnoea-Hypopnoea Index
Time frame: Baseline, Night 1
Number of apneas and hypopneas per hour of sleep.
Oxygen desaturation index
Time frame: Baseline, Night 1
Number of desaturations (drop in oxygen saturation \>3%) per hour of sleep
Drug induced sleep endoscopy
Time frame: Day 3
The VOTE classification system defines the degree of upper airway collapse at the level of the Velum (V), Oropharynx (O), Tongue (T) and Epiglottis (E). Collapse will be defined as either complete obstruction (2), partial obstruction (1) or no obstruction (0) at each level, and the pattern of collapse will be described at each level (antero-posterior for VTE, lateral for VOE, or concentric for V). Scoring will be conducted by three Investigators blinded to treatment allocation (i.e. baseline or with electrical stimulation). The three expert Investigators will review and come to consensus on scoring for each video.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Antwerp University HospitalEdegem, BelgiumStatus unknown
Study team and timeline
- Lead sponsor
- Notos Medical Limited
- Study start
- Jan 29, 2026 Actual
- Primary completion
- Aug 27, 2026 Actual
- Study completion
- Aug 27, 2026 Actual
- First posted
- Feb 9, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026