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

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ClinicalTrials.gov Identifier: NCT00467324
Recruitment Status : Unknown
Verified October 2008 by Aspire Medical.
Recruitment status was:  Active, not recruiting
First Posted : April 30, 2007
Last Update Posted : October 15, 2008
Sponsor:
Information provided by:
Aspire Medical

Brief Summary:
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).

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)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
Study Start Date : April 2007
Actual Primary Completion Date : October 2007
Estimated Study Completion Date : December 2008

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. Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Epworth Sleepiness Scale (ESS) measured at 6 months post-implantation [ Time Frame: 6 months ]
  2. Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 6 months post-implantation [ Time Frame: 6 months ]
  3. Safety: assessment of all device-related and procedure related adverse events and their seriousness [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00467324


Locations
United States, Georgia
Northside Hospital/Advanced Ear Nose & Throat Associates PC
Atlanta, Georgia, United States, 30342
United States, Indiana
St. Vincent's Hospital
Indianapolis, Indiana, United States, 46032
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53051
Sponsors and Collaborators
Aspire Medical
Investigators
Principal Investigator: Tucker Woodson, MD Department of OTO-HNS Medical College of Wisconsin

Additional Information:
Responsible Party: Jafar Shenasa, Director, Clinical and Regulatory Affairs, Aspire Medical, Inc.
ClinicalTrials.gov Identifier: NCT00467324     History of Changes
Other Study ID Numbers: TAS 002
First Posted: April 30, 2007    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

Keywords provided by Aspire Medical:
obstructive sleep apnea
surgery
tongue

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