Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome

October 13, 2016 updated by: Hopital Foch

Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea

Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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
      • Suresnes, France, 92150
        • Hôpital Foch

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sufficient teeth to allow wearing of the device
  • Mild to severe OSAS
  • Ability to answer the questionnaires
  • No concomitant CPAP treatment
  • BMI inferior to 32 kg/m2

Exclusion Criteria:

  • Important dental or parodontal disease
  • Central sleep apnea
  • Jaw opening limitations
  • Temporo-mandibular joint dysfunction
  • Major gag reflex precluding the long-term use of the device
  • Major or unstable cardiovascular or pulmonary disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propulsion type appliance (Herbst)
Device: Herbst (propulsion type oral appliance)
Oral appliance
Active Comparator: Retention type appliance (ORM)
Retention type appliance
Device: Retention type appliance (ORM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Hopital Foch

Investigators

  • Study Chair: Marc BLUMEN, MD, Hôpital FOCH 40, rue Worth 92150 Suresnes

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

May 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/05

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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