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

Part of paid clinical trials in Brighton, Massachusetts.

Sponsor
Linguaflex, Inc.
Study ID
NCT04129229
Status
Enrolling By Invitation

Conditions

  • Obstructive Sleep Apnea
  • Snoring

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LinguaFlex Tongue Retractor (LTR) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 10, 2020
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LTR Treatment
    Eligible subjects will undergo insertion of the LTR device in their tongue. Initiation of treatment will occur 7 days post insertion procedure and will be monitored over the course of 1 year.

Primary Outcome Measure

Responder to Therapy [ Time Frame: One Year ]

Locations (3)

FacilityCityStateZIPSite coordinators
St. Elizabeth's Medical CenterBrightonMassachusetts02135-
WVU Medicine / J. W. Ruby Memorial HospitalMorgantownWest Virginia26505-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Brighton, MA

By research site
St. Elizabeth's Medical Center· Brighton, MAWVU Medicine / J. W. Ruby Memorial Hospital· Morgantown, WVMedical College of Wisconsin· Milwaukee, WI

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