By InvitationNot Applicable

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

United States80 participantsStarted 2020-01-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Moderate to severe OSA (AHI of ≥ 15 to ≤ 50 as determined by a Diagnostic PSG recording within 2 months of inclusion)
✓. Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study

What they're measuring

Responder to Therapy

Timeframe: One Year

Trial details

NCT IDNCT04129229

SponsorLinguaflex, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials