Obstructive Sleep Apnea, OSA
Conditions
Brief summary
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).
Interventions
DEVICETranscutaneous Upper Airway Stimulation Device
Multiple frequency stimulation of the hypoglossal nerve
Sponsors
Somnial Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | Overnight (day 1) | Episodes of apnea and/or hypopnea scored during the course of sleep study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Oxygen Saturation (SaO2) | Overnight (day 1) | SaO2 levels during the course of sleep study compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | Overnight (day 1) | Subjective Questionnaire |
Countries
United States
Outcome results
None listed