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LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
Sponsor: Linguaflex, Inc.
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
Conditions
Interventions
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