NCT07396649

Feasibility of Upper Airway Stimulation in OSA

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Notos Medical Limited · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-01-29
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Belgium