Oral device for treatment of obstructive sleep apnea
Phase 2
- Conditions
- obstructive sleep apnea.Sleep apnoea
- Registration Number
- IRCT2014071618509N1
- Lead Sponsor
- Vice Chancellor for Research, Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Age more than 18 years, Willing to participate in the study, Having mild to moderate obstructive sleep apnea (Apnea Hypopnoea Index of 5 to 30), Having enough marginal dental adaptation
Exclusion criteria: Having Periodontal or other kind of oral cavity disease, Having contraindication for cephalometry (such as pregnancy), Having Advanced temporomandibular joint disease, Having contraindication for body MRI
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Apnea Hypopnea Index per hours during sleep. Timepoint: before intervention and 1 month after intervention. Method of measurement: polysomnography.
- Secondary Outcome Measures
Name Time Method Oropharyngeal volumetry. Timepoint: at the beginning, with and without Mandibular Advancement Splint in interventional group. Method of measurement: Oropharyngeal MRI.;Sleep quality and daytime sleepiness. Timepoint: before intervention and 1 month after intervention in interventional and control groups. Method of measurement: sleep quality questionnaire.