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Feasibility of Upper Airway Stimulation in OSA

NCT07396649 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnoea (OSA)

Interventions

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.

Sponsors & Collaborators

  • Notos Medical Limited

    lead INDUSTRY

Principal Investigators

  • Johan Verbraecken · Universiteit Antwerpen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07396649 on ClinicalTrials.gov