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

NCT05881512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-31

No results posted yet for this study

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

Interventions

DEVICE

Transcutaneous Upper Airway Stimulation Device

Multiple frequency stimulation of the hypoglossal nerve

Sponsors & Collaborators

  • Somnial Inc

    lead INDUSTRY

Principal Investigators

  • Lee Shangold, MD · ENT & Allergy Associates, LLP

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2022-09-18
Completion
2023-02-22
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881512 on ClinicalTrials.gov