NCT07396649

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 20, 2026

Last Update Submit

February 5, 2026

Conditions

Obstructive Sleep Apnoea (OSA)

Keywords

obstructive sleep apnoeaOSAsleep apnoea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Arousals

    Night 1

  • Subjective awareness of stimulation during sleep

    Night 1

Other Outcomes (4)

  • Respiratory disturbance index

    Baseline, Night 1

  • Apnoea-Hypopnoea Index

    Baseline, Night 1

  • Oxygen desaturation index

    Baseline, Night 1

  • +1 more other outcomes

Study Arms (1)

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.

Device: Non-invasive electrical stimulation

Interventions

Non-invasive electrical stimulationDEVICE

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.

Also known as: Breathe Study System
Non-invasive electrical stimulation of the upper airway

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Johan Verbraecken

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Assessors scoring the drug induced sleep endoscopy VOTE videos will be blinded to the treatment provided.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 9, 2026

Study Start

January 29, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)