Status:
UNKNOWN
The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
Lead Sponsor:
Aspire Medical
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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-hypop...
Detailed Description
Obstructive sleep apnea (OSA) is a major health problem in the United States and can result in excessive daytime sleepiness and cardiovascular problems. The primary treatment for OSA today is continuo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00467324
Start Date
April 1 2007
End Date
December 1 2008
Last Update
October 15 2008
Active Locations (4)
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1
Northside Hospital/Advanced Ear Nose & Throat Associates PC
Atlanta, Georgia, United States, 30342
2
St. Vincent's Hospital
Indianapolis, Indiana, United States, 46032
3
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
4
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53051