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

May 25, 2023 updated by: Somnial Inc
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Commack, New York, United States, 11725
        • United Diagnostics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index
Time Frame: Overnight (day 1)
Episodes of apnea and/or hypopnea scored during the course of sleep study
Overnight (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Oxygen Saturation (SaO2)
Time Frame: Overnight (day 1)
SaO2 levels during the course of sleep study compared to baseline
Overnight (day 1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: Overnight (day 1)
Subjective Questionnaire
Overnight (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somnial Inc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

September 18, 2022

Study Completion (Actual)

February 22, 2023

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOMN-001

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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