Obstructive Sleep Apnoea (OSA)NCT07396649
Feasibility of Upper Airway Stimulation in OSA
A study testing Non-invasive electrical stimulation in people with Obstructive Sleep Apnoea (OSA), run by Notos Medical Limited at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obstructive Sleep Apnoea (OSA)
- What is being tested?
- Non-invasive electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jan 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, 2650
Verena Iven, + 32 3 821 37 58, studies.slaapcentrum@uza.be
Johan Verbraecken
About this study
Official title: Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
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
- Obstructive Sleep Apnoea (OSA)
- Being tested
- Non-invasive electrical stimulation
- Keywords
- obstructive sleep apnoea, OSA, sleep apnoea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive electrical stimulationDevice
Also called Breathe Study System
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive electrical stimulation of the upper airway | Experimental | Participants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy. Receives: Device: Non-invasive electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of non-invasive electrical stimulation of the upper airway during sleep
The proportion of participants who are able to tolerate 80% of their maximum awake tolerated dose during sleep.
Measured: Night 1
Secondary outcomes (2)
Arousals
Number of arousals during sleep when patient is undergoing non-invasive electrical stimulation of the upper airway during respiratory events.
Measured: Night 1
Subjective awareness of stimulation during sleep
Number of actual stimulation events compared to number of events felt by the participant. Number of subjective events will be determined post-sleep.
Measured: Night 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start29 Jan 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Notos Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Verbraecken, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396649
- Sponsor's protocol ID
- CIV-25-10-054794
- Other IDs
- Project Breathe 1
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT07396649
- Acronym / sponsor ID
- CIV-25-10-054794
- Conditions
- Obstructive Sleep Apnoea (OSA)
- Keywords
- obstructive sleep apnoea, OSA, sleep apnoea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Notos Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive electrical stimulation of the upper airway | Experimental | Device: Non-invasive electrical stimulationParticipants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive electrical stimulationAlso: Breathe Study SystemThe 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. | Device | Non-invasive electrical stimulation of the upper airway |
Primary outcome
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.
2 secondary outcomes
Arousals
Time frame: Night 1
Subjective awareness of stimulation during sleep
Time frame: Night 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnoea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan Verbraecken principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive electrical stimulation in people with Obstructive Sleep Apnoea (OSA), run by Notos Medical Limited at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of non-invasive electrical stimulation of the upper airway during sleep (time frame: Night 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.