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

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).

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: Aspire Medical Advance System

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital/Advanced Ear Nose & Throat Associates PC
  • Indiana
    • Indianapolis, Indiana, United States, 46032
      • St. Vincent's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53051
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System	6 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Aspire Medical
• Investigators: Principal Investigator: Tucker Woodson, MD, Department of OTO-HNS Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): October 1, 2007
• Study Completion (ANTICIPATED): December 1, 2008

Study Registration Dates

• First Submitted: April 26, 2007
• First Submitted That Met QC Criteria: April 26, 2007
• First Posted (ESTIMATE): April 30, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2008
• Last Update Submitted That Met QC Criteria: October 13, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: surgery; obstructive sleep apnea; tongue
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: TAS 002