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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subjects able to read, understand and sign consent
* Subjects 18 years or older with:
1. Moderate to severe OSA (AHI of ≥ 15 to ≤ 50 as determined by a Diagnostic PSG recording within 2 months of inclusion)
2. Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study
Exclusion Criteria:
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
Primary outcome measure(s)
Responder to Therapy — One Year Determine the responder rate to therapy. A responder is defined as a subject who experiences a ≥ 50% reduction in AHI from baseline and has an AHI \< 20 at the 12-month follow-up visit. Subjects with an AHI ≤ 20 at baseline will be considered a responder if a 50% reduction in AHI is achieved from baseline.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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