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

NCT00467324 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2008-10-15

No results posted yet for this study

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).

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

  • Tucker Woodson, MD · Department of OTO-HNS Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-10-31
Completion
2008-12-31

Countries

  • United States

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 NCT00467324 on ClinicalTrials.gov