Feasibility of Upper Airway Stimulation in OSA
ConditionObstructive Sleep Apnoea (OSA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNotos Medical Limited
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Non-invasive electrical stimulation
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov