LTR for Treatment of Obstructive Sleep Apnea

Linguaflex

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Linguaflex Tongue Retractor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03066765

LTR-005-V01.2

Details and patient eligibility

About

Study of tongue implant for treatment of obstructive sleep apnea

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

LTR Treatment

Experimental group

Description:

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

Treatment:

Device: Linguaflex Tongue Retractor