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ENROLLING BY INVITATION
NCT04129229
NA

LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults

Sponsor: Linguaflex, Inc.

View on ClinicalTrials.gov

Summary

The LinguaFlex™ Tongue Retractor (LTR) is an investigational medical device that is inserted into the tongue to lessen its backward movement during sleep. This helps to keep the airway open during sleep so that the tongue doesn't block the airway causing obstructive apnea or narrow it enough to cause snoring. This study will monitor the effectiveness of the LTR device in the reduction of Obstructive Sleep Apnea and snoring over the course of a one-year treatment period.

Official title: Non-Randomized, Multi-Site, Single-Arm Study of the LinguaFlex™ Tongue Retractor (LTR) for the Treatment of Moderate to Severe Obstructive Sleep Apnea and Snoring in Adult Subjects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2020-01-10

Completion Date

2026-04

Last Updated

2024-10-09

Healthy Volunteers

No

Interventions

DEVICE

LinguaFlex Tongue Retractor (LTR)

The LinguaFlex Tongue Retractor (LTR) is a small, flexible, implanted tongue retaining device that lessens the backward movement of the tongue during sleep. The LTR's flexible shaft and a nubbed tether passes through the center of the tongue beneath the tongue blade (frenulum area) and connects to a disc (head) that rests on the external surface of the tongue base mucosa. Underneath the tongue, on the external surface of the frenulum, a small anchor secures the shaft that can be adjusted to tension the LTR to maximize therapeutic effect and maintain comfort.

Locations (3)

St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

WVU Medicine / J. W. Ruby Memorial Hospital

Morgantown, West Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States