Tongue Advancement for Obstructive Sleep Apnea

Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.

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.

Study Overview

• Status: Completed
• 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 (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Egedem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
• Czech Republic
  • Plzen, Czech Republic, 320 04
    • LENTE
• Germany
  • Mannheim, Germany, 68135
    • University Hospital Mannheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Demonstrate the feasibility of tongue stabilization using the Advance™ System. Product implantation and stabilization of the tongue using the Advance™system will be measured by Pharyngoscopy and Cephalogram	3 months
Evaluate the safety of the Advance™ System 3 Months after implantation.	3 months
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation	3 months
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation	3 months

Collaborators and Investigators

• Sponsor: Aspire Medical
• Investigators: Principal Investigator: Boris A. Stuck, MD, Deparment of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim; Principal Investigator: Evert Hamans, MD, Department of Otorhinolaryngology, University Hospital Antwerp

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: June 21, 2007
• First Submitted That Met QC Criteria: June 21, 2007
• First Posted (Estimate): June 25, 2007

Study Record Updates

• Last Update Posted (Estimate): December 23, 2009
• Last Update Submitted That Met QC Criteria: December 22, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: surgery; tongue; obstructive sleep apena
• 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 001