Back to resultsTongue Advancement for Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Aspire Medical Advance System
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring obstructive sleep apena, tongue, surgery
Eligibility 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
Sites / Locations
- Universitair Ziekenhuis Antwerpen
- LENTE
- University Hospital Mannheim
Outcomes
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
Evaluate the safety of the Advance™ System 3 Months after implantation.
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.
Secondary Outcome Measures
Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00490984
Brief Title
Tongue Advancement for Obstructive Sleep Apnea
Official Title
Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aspire Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
obstructive sleep apena, tongue, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Aspire Medical Advance System
Intervention Description
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 Measure Information:
Title
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
Title
Evaluate the safety of the Advance™ System 3 Months after implantation.
Time Frame
3 months
Title
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation
Time Frame
3 months
Title
Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris A. Stuck, MD
Organizational Affiliation
Deparment of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evert Hamans, MD
Organizational Affiliation
Department of Otorhinolaryngology, University Hospital Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Egedem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
LENTE
City
Plzen
ZIP/Postal Code
320 04
Country
Czech Republic
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68135
Country
Germany
12. IPD Sharing Statement
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Tongue Advancement for Obstructive Sleep Apnea
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