Clinical trial NCT00467324: The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
Official title: The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: obstructive sleep apnea
surgery
tongue
Lead sponsor: Aspire Medical
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System
timeFrame: 6 months
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS) measured at 6 months post-implantation
timeFrame: 6 months
measure: Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 6 months post-implantation
timeFrame: 6 months
measure: Safety: assessment of all device-related and procedure related adverse events and their seriousness
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital/Advanced Ear Nose & Throat Associates PC
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Department of OTO-HNS Medical College of Wisconsin
name: Tucker Woodson, MD
role: PRINCIPAL_INVESTIGATOR
References: