LTR for Treatment of Obstructive Sleep Apnea

Linguaflex, Inc.16 enrolled

Overview

Study of tongue implant for treatment of obstructive sleep apnea

Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. Subjects will be followed a year with primary endpoint of AHI results through Polysomnography readings (PSG) testing in an overnight sleep lab.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Linguaflex Tongue RetractorDEVICE

Tongue implant

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * AHI\>10 * 18 years of age Exclusion Criteria: * Subjects with \>20% of their AHI accounted for from central apnea. * Mallampanti score of 4 * Tonsillar hypertrophy (4+) * Prior uvulopalatopharyngoplasty (UPPP) procedure * Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray * Tongue thickness \<40 mm measured on lateral cephalogram x-ray from the frenulum to linea terminalis * More than 10% of sleep time with blood O2 desaturation below 70% * Unable and/or unwilling to comply with study requirements * Females of child bearing age who are pregnant or intending to become pregnant * Allergy to silicone * History of radiation therapy to neck or upper respiratory tract * Subjects with bleeding disorders, impaired immunity for any reason, or heart attack within the last six months

Outcomes

Primary Outcomes

Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing

Recording of Apnea Hypopnea Index through polysomnography during overnight sleep study

Time frame: 1 year

Secondary Outcomes

Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device

Assessment of Adverse Events and Serious Adverse Events

Time frame: 1 year

Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale

Assess level of sleepiness pre and post treatment

Time frame: 1 year

Data from ClinicalTrials.gov

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