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NCT Number: NCT07396649

Feasibility of Upper Airway Stimulation in OSA

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.

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Key information

Conditions

Obstructive Sleep Apnoea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, 2650, Belgium

Location status: Recruiting

Location contact

Johan Verbraecken

PRINCIPAL_INVESTIGATOR

Verena Iven

CONTACT

[email protected]

+ 32 3 821 37 58

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

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.

Other names: Breathe Study System

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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 outcomes

  1. Respiratory disturbance index

    Time frame: Baseline, Night 1

    Number of arousals from respiratory events. Only arousals during which stimulation was initiated will be included.

  2. Apnoea-Hypopnoea Index

    Time frame: Baseline, Night 1

    Number of apneas and hypopneas per hour of sleep.

  3. Oxygen desaturation index

    Time frame: Baseline, Night 1

    Number of desaturations (drop in oxygen saturation >3%) per hour of sleep

  4. 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.

Sponsors and collaborators

Lead sponsor

Notos Medical Limited

Industry

Registry information

Official study title

Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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