search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea, OSA

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Upper Airway Stimulation Device
Sponsored by
Somnial Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • United Diagnostics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TUAS

Arm Description

Transcutaneous upper airway stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Arterial Oxygen Saturation (SaO2)
SaO2 levels during the course of sleep study compared to baseline

Full Information

First Posted
May 8, 2023
Last Updated
May 25, 2023
Sponsor
Somnial Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT05881512
Brief Title
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Official Title
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
September 18, 2022 (Actual)
Study Completion Date
February 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Somnial Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, OSA

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TUAS
Arm Type
Experimental
Arm Description
Transcutaneous upper airway stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous Upper Airway Stimulation Device
Other Intervention Name(s)
TUAS
Intervention Description
Multiple frequency stimulation of the hypoglossal nerve
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
Episodes of apnea and/or hypopnea scored during the course of sleep study
Time Frame
Overnight (day 1)
Secondary Outcome Measure Information:
Title
Arterial Oxygen Saturation (SaO2)
Description
SaO2 levels during the course of sleep study compared to baseline
Time Frame
Overnight (day 1)
Other Pre-specified Outcome Measures:
Title
Sleep Quality
Description
Subjective Questionnaire
Time Frame
Overnight (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Shangold, MD
Organizational Affiliation
ENT & Allergy Associates, LLP
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Diagnostics
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs