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Tongue Advancement for Obstructive Sleep Apnea

NCT00490984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-12-23

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

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.

Sponsors & Collaborators

  • Aspire Medical

    lead INDUSTRY

Principal Investigators

  • Boris A. Stuck, MD · Deparment of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim

  • Evert Hamans, MD · Department of Otorhinolaryngology, University Hospital Antwerp

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-02-28
Completion
2009-07-31

Countries

  • Belgium
  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490984 on ClinicalTrials.gov