The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System

Status unconfirmed · Not applicable

Conditions studied: Sleep Apnea, Obstructive

In brief

The objective of the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography (PSG).

Key facts

Study ID

NCT00467324

Run by

Aspire Medical

People needed

42

Starts

2007-04-01

Expected to finish

2008-12-01

Last updated by the study team

2008-10-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously diagnosed or screened with moderate to severe sleep apnea who have an AHI of between 15 and 60
• Age between 18 and 65
• Body mass index (BMI) </= 32
• Patient has been offered CPAP and has refused or failed to continue CPAP treatment
• Identified evidence of airway collapse at the base of the tongue
• Signed informed consent

You may not qualify if…

• Prior OSA surgery except tonsillectomy, adenoidectomy, and nasal surgery
• Enlarged tonsils (3+ and 4+)
• Anatomy unable to accommodate the implant
• Severe mandibular deficiency/retrognathia
• Significant rhinitis/nasal obstruction
• Unable and/or not willing to comply with treatment follow-up requirements
• Pregnancy (female subjects of childbearing age mus have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study) or breastfeeding
• Active systemic infection
• Allergy to latex or any medication used during implantation
• Previous history of neck or upper respiratory tract cancer
• History of radiation therapy to neck or upper respiratory tract
• Dysphagia
• History of major cardiovascular disorders including MI, angina, uncontrolled hypertension, and CHF
• Major pulmonary disorders including COPD and uncontrolled asthma
• Patient is suffering from untreated/inadequately treated major depression, as determined by history
• History of falling asleep driving or motor vehicle accident secondary to excessive sleepiness
• Anesthesia risk group ASA Class IV or V
• Other medical, social or psychological problems that, in the opinion of the investigator, could complicate the procedure and/or recovery from this treatment or could complicate the procedures and evaluations pre- and post-treatment
• Enrollment in another pharmacological or medical device study

Where it is running

• Northside Hospital/Advanced Ear Nose & Throat Associates PC — Atlanta, Georgia, United States
• St. Vincent's Hospital — Indianapolis, Indiana, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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