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

NCT05881512 | Completed FDA Device

• 1 other identifier: SOMN-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea; OSA

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index

  Episodes of apnea and/or hypopnea scored during the course of sleep study

  Overnight (day 1)

Secondary Outcomes (1)

• Arterial Oxygen Saturation (SaO2)

  Overnight (day 1)

Other Outcomes (1)

• Sleep Quality

  Overnight (day 1)

Study Arms (1)

TUAS

EXPERIMENTAL

Transcutaneous upper airway stimulation

Device: Transcutaneous Upper Airway Stimulation Device

Interventions

Transcutaneous Upper Airway Stimulation Device DEVICE

Multiple frequency stimulation of the hypoglossal nerve

Also known as: TUAS

TUAS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Somnial Inc: lead

Study Sites (1)

United Diagnostics

Commack, New York, 11725, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Lee Shangold, MD

  ENT & Allergy Associates, LLP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 31, 2023
• Study Start: September 12, 2022
• Primary Completion: September 18, 2022
• Study Completion: February 22, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

US (1)