Back to resultsComparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome
Primary Purpose
Obstructive Sleep Apnea
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Herbst (propulsion type oral appliance)
Retention type appliance (ORM)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Hôpital FOCH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propulsion type appliance (Herbst)
Retention type appliance (ORM)
Arm Description
Retention type appliance
Outcomes
Primary Outcome Measures
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02763813
Brief Title
Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome
Official Title
Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propulsion type appliance (Herbst)
Arm Type
Experimental
Arm Title
Retention type appliance (ORM)
Arm Type
Active Comparator
Arm Description
Retention type appliance
Intervention Type
Device
Intervention Name(s)
Herbst (propulsion type oral appliance)
Intervention Description
Oral appliance
Intervention Type
Device
Intervention Name(s)
Retention type appliance (ORM)
Primary Outcome Measure Information:
Title
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc BLUMEN, MD
Organizational Affiliation
Hôpital FOCH 40, rue Worth 92150 Suresnes
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital FOCH
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome
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