The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
NCT ID: NCT00467324
Last Updated: 2008-10-15
Study Results
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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UNKNOWN
NA
42 participants
INTERVENTIONAL
2007-04-30
2008-12-31
Brief Summary
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Detailed Description
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This trial will measure the effectiveness of the Advance System, an implantable medical device to treat OSA. In the trial, patients who meet the study entry criteria receive a baseline sleep study (PSG). The Advance System is then implanted and 6 months after implantation, another PSG is performed. The trial will compare the baseline and the 6 month apnea-hypopnea indices
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Aspire Medical Advance System
The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Aspire Medical
INDUSTRY
Responsible Party
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Aspire Medical, Inc.
Principal Investigators
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Tucker Woodson, MD
Role: PRINCIPAL_INVESTIGATOR
Department of OTO-HNS Medical College of Wisconsin
Locations
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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
Countries
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Related Links
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Sponsor's web site; has basic product \& patient information
Other Identifiers
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TAS 002
Identifier Type: -
Identifier Source: org_study_id