Obstructive Sleep Apnea Clinical Trial
Official title:
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | February 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital FOCH | Suresnes |
Lead Sponsor | Collaborator |
---|---|
Hopital Foch |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography) | 12 months | No |
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