Sleep Apnea, Obstructive
Conditions
Keywords
obstructive sleep apnea, surgery, tongue
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-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography (PSG).
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 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
Interventions
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.
Sponsors
Aspire Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Epworth Sleepiness Scale (ESS) measured at 6 months post-implantation | 6 months |
| Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 6 months post-implantation | 6 months |
| Safety: assessment of all device-related and procedure related adverse events and their seriousness | 6 months |
Countries
United States
Outcome results
None listed