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

Sponsor
Somnial Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT05881512
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
5.4
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Transcutaneous Upper Airway Stimulation Device
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Actual Study Start Date :
Sep 12, 2022
Actual Primary Completion Date :
Sep 18, 2022
Actual Study Completion Date :
Feb 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TUAS

Transcutaneous upper airway stimulation

Device: Transcutaneous Upper Airway Stimulation Device
Multiple frequency stimulation of the hypoglossal nerve
Other Names:
  • TUAS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Apnea Hypopnea Index [Overnight (day 1)]

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

    Secondary Outcome Measures

    1. Arterial Oxygen Saturation (SaO2) [Overnight (day 1)]

      SaO2 levels during the course of sleep study compared to baseline

    Other Outcome Measures

    1. Sleep Quality [Overnight (day 1)]

      Subjective Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 United Diagnostics Commack New York United States 11725

    Sponsors and Collaborators

    • Somnial Inc

    Investigators

    • Principal Investigator: Lee Shangold, MD, ENT & Allergy Associates, LLP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Somnial Inc
    ClinicalTrials.gov Identifier:
    NCT05881512
    Other Study ID Numbers:
    • SOMN-001
    First Posted:
    May 31, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive

    Study Results

    No Results Posted as of May 31, 2023