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

Aspire Medical

Status

Unknown

Conditions

Sleep Apnea, Obstructive

Treatments

Device: Aspire Medical Advance System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00467324

TAS 002

Details and patient eligibility

About

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).

Full 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 continuous positive airway pressure (CPAP). Many patients however are unable to tolerate sleeping with a CPAP machine. Surgery is one of the main treatment options available today to these CPAP-intolerant patients. However, current methods of sleep surgery are painful, morbid, and/or lack decent effectiveness.

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

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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