LTR for Treatment of Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Linguaflex Tongue Retractor

• Registration Number: NCT03066765
• Lead Sponsor: Linguaflex, Inc.

Brief Summary

Study of tongue implant for treatment of obstructive sleep apnea

Detailed Description

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 Timeline

• Study Start: 2016-02-25
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-02-28
• Primary Completion: 2017-11-21
• Study Completion: 2018-02-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LTR Treatment	Linguaflex Tongue Retractor	An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy

Primary Outcome Measures

Name	Time	Method
Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing	1 year	Recording of Apnea Hypopnea Index through polysomnography during overnight sleep study

Secondary Outcome Measures

Name	Time	Method
Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale	1 year	Assess level of sleepiness pre and post treatment
Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device	1 year	Assessment of Adverse Events and Serious Adverse Events