LTR for Treatment of Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-25

Study Completion Date

2018-02-05

Brief Summary

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Study of tongue implant for treatment of obstructive sleep apnea

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LTR Treatment

An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy

Group Type EXPERIMENTAL

Linguaflex Tongue Retractor

Intervention Type DEVICE

Tongue implant

Interventions

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Linguaflex Tongue Retractor

Tongue implant

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes