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

June 21, 2007
December 22, 2009
February 2006
February 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00490984 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sleep Apnea, Obstructive
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany
 
NCT00490984
TAS 001
Yes
Jafar Shenasa, Director, Clinical and Regulatory Affairs, Aspire Medical, Inc.
Aspire Medical
Not Provided
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
Aspire Medical
April 2009

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