LTR for Treatment of Obstructive Sleep Apnea

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

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.

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