Tongue Advancement for Obstructive Sleep Apnea

Aspire Medical

Status

Completed

Conditions

Sleep Apnea, Obstructive

Treatments

Device: Aspire Medical Advance System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00490984

TAS 001

Details and patient eligibility

About

The objective of this study is to assess the feasibility, safety and effectiveness of tongue stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by polysomnography (PSG) from baseline to 6 months.

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

60 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented diagnosis of obstructive sleep apnea with AHI 15-50 measured within a year prior to enrollment with no major change in BMI
Bewteen 20 and 65 years old
Body Mass Index (BMI) ≤ 32
Patient has been offered CPAP and has refused or failed to continue CPAP treatment
Identified evidence of airway collapse, primarily at the base of the tongue
Signed informed consent to participate in this clinical study

Exclusion criteria

Prior OSA surgery except tonsillectomy, nasal surgery and uvulopalatopharyngoplasty; no airway surgery within 3 months prior to enrollment.
Airway collapse at the level of the soft palate (palatal collapse).
Enlarged tonsils (3+ and 4+)
Anatomy unable to accommodate the implant
Severe mandibular deficiency/retrognathia
Unable and/or not willing to comply with treatment follow-up requirements.
Pregnancy. (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study)
Breastfeeding women
Active systemic infection
Allergy to 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
Major cardiovascular and pulmonary disorders
Other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment
Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study