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

Somnial

Status

Completed

Conditions

OSA

Obstructive Sleep Apnea

Treatments

Device: Transcutaneous Upper Airway Stimulation Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT05881512

SOMN-001

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.