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

Enrolling by invitation · Not applicable

Conditions studied: Obstructive Sleep Apnea, Snoring

In brief

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 facts

Study ID

NCT04129229

Run by

Linguaflex, Inc.

People needed

80

Starts

2020-01-10

Expected to finish

2026-04-01

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects able to read, understand and sign consent
• Subjects 18 years or older with:
• 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

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from participation in the clinical trial:
• < 18 years of age
• AHI < 15(mild OSA)
• AHI > 50
• Subjects with > 20% of AHI score accounted for from central apnea
• More than 10% of Total Sleep Time (TST) with blood O2 saturation (SaO2) below 70%
• Subjects successfully treated with prescribed PAP therapy
• Tonsillar hypertrophy ≥3
• Subjects with significant active comorbid respiratory or cardiac disease (such as COPD or Heart Failure)
• Subjects requiring regular use of supplemental oxygen
• Nasal airway obstruction as seen on examination
• Congenital malformations of the upper airway, larynx, pharynx, oral cavity or tongue
• Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination (suspected epiglottic obstruction)
• History of radiation therapy to the neck or upper respiratory tract
• Subjects with bleeding disorders, unresolved impaired immunity for any reason, or heart attack within the last six months
• Subjects with an existing tongue stud/piercing
• Females who are pregnant (anesthesia risk)
• Allergy to LTR materials (Silicone, PEEK, Polyurethane)
• Subjects who have in the surgeon's judgment unusual anatomy that would interfere with treatment or increase the risk for the procedure
• Unable and/or unwilling to comply with study requirements

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.