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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; OSA
• Interventions: Device: Transcutaneous Upper Airway Stimulation Device

• Registration Number: NCT05881512
• Lead Sponsor: Somnial Inc

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-12
• Primary Completion: 2022-09-18
• Study Completion: 2023-02-22
• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TUAS	Transcutaneous Upper Airway Stimulation Device	Transcutaneous upper airway stimulation

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	Overnight (day 1)	Episodes of apnea and/or hypopnea scored during the course of sleep study

Secondary Outcome Measures

Name	Time	Method
Arterial Oxygen Saturation (SaO2)	Overnight (day 1)	SaO2 levels during the course of sleep study compared to baseline

Trial Locations

Locations (1)

United Diagnostics; 🇺🇸 Commack, New York, United States