VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea (VASO-AM)

December 12, 2016 updated by: University Hospital, Angers
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38100
        • CHU Grenoble
      • Le Mans, France, 72100
        • CH Le Mans
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Poitiers, France, 86000
        • CHU Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AHI > 30
  • Intolerance to CPAP therapy
  • Signed informed consent

Exclusion Criteria:

  • Epworth sleepiness scale > 16/24
  • Severe cardiac and/or respiratory disease
  • BMI>32 kg/m2
  • Dental contraindication to oral appliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMO
Adjustable mandibular repositioning appliance
Device: AMO
Placebo Comparator: placebo
placebo device in upper jaw
Device: AMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline to 2-months in markers of OSA severity
Time Frame: 2 months
2 months
change from baseline to 2-months in blood pressure
Time Frame: 2 months
2 months
change from baseline to 2-months in symptoms of OSA
Time Frame: 2 months
2 months
evaluate treatment compliance objectively measured by an embedded micro sensor
Time Frame: 15 weeks
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2010-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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