LTR for Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Study of tongue implant for treatment of obstructive sleep apnea

Detailed Description
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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.

Official Title
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Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Linguaflex Tongue Retractor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTR Treatment<br>An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy | Device: Linguaflex Tongue Retractor<br>* Tongue implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 year |