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Obstructive Sleep Apnea
+1

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

Sponsored by Linguaflex, Inc.

About this trial

Last updated 2 years ago

Study ID

LTR-006-V02.0-US-CTP

Status

Enrolling by invitation

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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
No

Exclusion Criteria

- < 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