Feasibility of Upper Airway Stimulation in OSA

Recruiting N/A Interventional Study
Obstructive Sleep Apnoea (OSA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
19 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Notos Medical Limited · Industry
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About This Trial

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 Locations
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Eligibility Criteria
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 c…
Contacts

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