Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome
Not Applicable
Terminated
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Herbst (propulsion type oral appliance)Device: Retention type appliance (ORM)
- Registration Number
- NCT02763813
- Lead Sponsor
- Hopital Foch
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propulsion type appliance (Herbst) Herbst (propulsion type oral appliance) - Retention type appliance (ORM) Retention type appliance (ORM) Retention type appliance
- Primary Outcome Measures
Name Time Method Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography) 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital FOCH
🇫🇷Suresnes, France