NCT00490984

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

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

February 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 23, 2009

Status Verified

April 1, 2009

Enrollment Period

3 years

First QC Date

June 21, 2007

Last Update Submit

December 22, 2009

Conditions

Sleep Apnea, Obstructive

Keywords

obstructive sleep apenatonguesurgery

Outcome Measures

Primary Outcomes (3)

  • 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

    3 months

  • Evaluate the safety of the Advance™ System 3 Months after implantation.

    3 months

  • Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.

    6 months

Secondary Outcomes (2)

  • Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation

    3 months

  • Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation

    3 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

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitair Ziekenhuis Antwerpen

Egedem, 2650, Belgium

Location

LENTE

Pilsen, 320 04, Czechia

Location

University Hospital Mannheim

Mannheim, 68135, Germany

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

  • 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

    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

June 21, 2007

First Posted

June 25, 2007

Study Start

February 1, 2006

Primary Completion

February 1, 2009

Study Completion

July 1, 2009

Last Updated

December 23, 2009

Record last verified: 2009-04

Locations

CZ(1)DE(1)BE(1)