Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).

Official Title
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Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea, OSA

Intervention / Treatment
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* Device: Transcutaneous Upper Airway Stimulation Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 years or older In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, <25% of the respiratory events on the diagnostic PSG can be attributed to central apneas BMI less than or equal to 32 Exclusion Criteria: No or mild OSA (AHI <15/h) or very severe OSA (AHI >50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA. Patients who are cachectic (BMI <18.5 kg/m2) or obese (BMI >32 kg/m2). Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers. Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TUAS<br>Transcutaneous upper airway stimulation | Device: Transcutaneous Upper Airway Stimulation Device<br>* Multiple frequency stimulation of the hypoglossal nerve<br>* Other names: TUAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index | Episodes of apnea and/or hypopnea scored during the course of sleep study | Overnight (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Oxygen Saturation (SaO2) | SaO2 levels during the course of sleep study compared to baseline | Overnight (day 1) |