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โ† Trials
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Feasibility of Upper Airway Stimulation in OSA

RecruitingNAAges 19 Years - anyAllNotos Medical Limited
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Obstructive sleep apnoea diagnosis with an AHI of 15-50 events/hour recorded in the baseline polysomnography (PSG) * BMI \< 32 kg/mยฒ * Age \> 18 years old * Able to read, write, and speak Dutch with acceptable visual and auditory acuity * Able and willing to provide informed consent Exclusion Criteria: * 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)
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What it tests

  • Non-invasive electrical stimulation
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Where

1 site
Antwerp University Hospital
Edegem, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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