Tongue Advancement for Obstructive Sleep Apnea

This study has been completed.

Sponsor:

Information provided by:

Aspire Medical

ClinicalTrials.gov Identifier:

NCT00490984

First received: June 21, 2007

Last updated: December 22, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 21, 2007

Last Updated Date

December 22, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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: 2 months ]
Evaluate the safety of the Advance™ System 2 Months after implantation. [ Time Frame: 2 months ]
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies. [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00490984 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Epworth Sleepiness Scale (ESS) measured at 2 Months post-implantation [ Time Frame: 2 months ]
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 2 Months post-implantation [ Time Frame: 2 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tongue Advancement for Obstructive Sleep Apnea

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Sleep Apnea, Obstructive

Intervention ^ICMJE

Device: Aspire Medical Advance System

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Czech Republic, Germany

Administrative Information

NCT Number ^ICMJE

NCT00490984

Other Study ID Numbers ^ICMJE

TAS 001

Has Data Monitoring Committee

Yes

Responsible Party

Jafar Shenasa, Director, Clinical and Regulatory Affairs, Aspire Medical, Inc.

Study Sponsor ^ICMJE

Aspire Medical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Aspire Medical

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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