Tongue Advancement for Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490984
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : December 23, 2009
Information provided by:
Aspire Medical

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Aspire Medical Advance System Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.
Study Start Date : February 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]
  2. Evaluate the safety of the Advance™ System 3 Months after implantation. [ Time Frame: 3 months ]
  3. Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation [ Time Frame: 3 months ]
  2. Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00490984

Universitair Ziekenhuis Antwerpen
Egedem, Belgium, 2650
Czech Republic
Plzen, Czech Republic, 320 04
University Hospital Mannheim
Mannheim, Germany, 68135
Sponsors and Collaborators
Aspire Medical
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

Responsible Party: Jafar Shenasa, Director, Clinical and Regulatory Affairs, Aspire Medical, Inc. Identifier: NCT00490984     History of Changes
Other Study ID Numbers: TAS 001
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: April 2009

Keywords provided by Aspire Medical:
obstructive sleep apena

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases