Feasibility of Upper Airway Stimulation in OSA

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnoea (OSA)
• Intervention / Treatment: Device: Non-invasive electrical stimulation

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • Antwerp University Hospital
    • Contact: Verena Iven; Phone Number: + 32 3 821 37 58; Email: studies.slaapcentrum@uza.be
    • Principal Investigator: Johan Verbraecken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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; 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.; Other Names: Breathe Study System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Night 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arousals	Number of arousals during sleep when patient is undergoing non-invasive electrical stimulation of the upper airway during respiratory events.	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.	Night 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory disturbance index	Number of arousals from respiratory events. Only arousals during which stimulation was initiated will be included.	Baseline, Night 1
Apnoea-Hypopnoea Index	Number of apneas and hypopneas per hour of sleep.	Baseline, Night 1
Oxygen desaturation index	Number of desaturations (drop in oxygen saturation >3%) per hour of sleep	Baseline, Night 1
Drug induced sleep endoscopy	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.	Day 3

Collaborators and Investigators

• Sponsor: Notos Medical Limited
• Investigators: Principal Investigator: Johan Verbraecken, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: OSA; obstructive sleep apnoea; sleep apnoea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIV-25-10-054794; Project Breathe 1 (Other Identifier: Notos Medical Limited)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No