NCT00467324

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

Enrollment Period

6 months

First QC Date

April 26, 2007

Last Update Submit

October 13, 2008

Conditions

Sleep Apnea, Obstructive

Keywords

obstructive sleep apneasurgerytongue

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (3)

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

    6 months

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

    6 months

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

    6 months

Interventions

Aspire Medical Advance SystemDEVICE

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Northside Hospital/Advanced Ear Nose & Throat Associates PC

Atlanta, Georgia, 30342, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46032, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53051, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Tucker Woodson, MD

    Department of OTO-HNS Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 30, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2007

Study Completion

December 1, 2008

Last Updated

October 15, 2008

Record last verified: 2008-10

Locations

US(4)