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

Primary Purpose

Sleep Apnea, Obstructive

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aspire Medical Advance System

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring obstructive sleep apnea, surgery, tongue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northside Hospital/Advanced Ear Nose & Throat Associates PC
St. Vincent's Hospital
University of Cincinnati Medical Center
Medical College of Wisconsin

Outcomes

Primary Outcome Measures

Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System

Secondary Outcome Measures

Epworth Sleepiness Scale (ESS) measured at 6 months post-implantation

Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 6 months post-implantation

Safety: assessment of all device-related and procedure related adverse events and their seriousness

Full Information

NCT ID

NCT00467324

First Posted

April 26, 2007

Last Updated

October 13, 2008

Sponsor

Aspire Medical

1. Study Identification

Unique Protocol Identification Number

NCT00467324

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Aspire Medical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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 apnea, surgery, tongue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

42 (Actual)

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

Apnea hypopnea index measured with polysomnography 6 months after implantation of the Advance System

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Epworth Sleepiness Scale (ESS) measured at 6 months post-implantation

Time Frame

6 months

Title

Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 6 months post-implantation

Time Frame

6 months

Title

Safety: assessment of all device-related and procedure related adverse events and their seriousness

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tucker Woodson, MD

Organizational Affiliation

Department of OTO-HNS Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northside Hospital/Advanced Ear Nose & Throat Associates PC

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

St. Vincent's Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46032

Country

United States

Facility Name

University of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53051

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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