Tongue Advancement for Obstructive Sleep Apnea - Full Text View

Purpose

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.

Condition	Intervention
Sleep Apnea, Obstructive	Device: Aspire Medical Advance System

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Aspire Medical:

Primary Outcome Measures:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Evaluate the safety of the Advance™ System 3 Months after implantation. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2006
Study Completion Date:	July 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490984

Locations

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

Sponsors and Collaborators

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

More Information

Additional Information:

Sponsor's web site; has basic product & patient information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jafar Shenasa, Director, Clinical and Regulatory Affairs, Aspire Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00490984 History of Changes
Other Study ID Numbers:	TAS 001
Study First Received:	June 21, 2007
Last Updated:	December 22, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Aspire Medical:

obstructive sleep apena
tongue
surgery

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013