Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese
NCT ID: NCT03517150
Last Updated: 2018-05-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-05-12
Study Completion Date
2018-06-12
Brief Summary
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This study evaluates the effectiveness of intraoral appliance in the treatment of obstructive sleep Apnea Syndrome in class III obese in comparison to an adjustable silicone appliance. Both treatments will be test by all of the participants and they will make the polysomnography exam to have the outcomes.
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Detailed Description
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Conditions
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Obstructive Sleep Apnea
Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Experimental group
This group will use an oral appliance for treatment of obstructive sleep apnea. The oral appliance is custom-made and its titration is attained by means of progressive mandibular advancement that incrementally moves the mandible forward. This group of patients will use the oral appliance for 45 days.
Group Type
EXPERIMENTAL
mandibular advancement device
Intervention Type
DEVICE
Control group
This group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group.
Group Type
ACTIVE_COMPARATOR
mandibular advancement device
Intervention Type
DEVICE
Interventions
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mandibular advancement device
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* BMI ≥40 kg/m² and ≤ 49,9 kg/m²
* Female and male patients (Both of gender patients) with ages between 20 to 65 years old
* Obstructive Sleep Apnea (OSA) diagnosis by polysomnography
* Female and male patients (Both of gender patients) with ages between 20 to 65 years old
* Obstructive Sleep Apnea (OSA) diagnosis by polysomnography
Exclusion Criteria
* sedative drugs users
* Oxygen-dependent or decompensated lung disease
* Decompensated congestive heart failure
* Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia)
* craniofacial deformities carriers
* previous OSAS Diagnosis and treatment
* Active Oncological diseases in the last ten years
* Patients with less than 8 teeth per arcade;
* Patients with advanced periodontitis;
* Oxygen-dependent or decompensated lung disease
* Decompensated congestive heart failure
* Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia)
* craniofacial deformities carriers
* previous OSAS Diagnosis and treatment
* Active Oncological diseases in the last ten years
* Patients with less than 8 teeth per arcade;
* Patients with advanced periodontitis;
Minimum Eligible Age
20 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Sao Paulo
OTHER
Sponsor Role
lead
Responsible Party
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Silvia de Carvalho Alvarenga
principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
References
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RESULT
Related Links
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http://www.aasmnet.org/store/product.aspx?pid=10
American Academy of Sleep Medicine
Other Identifiers
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FOB apnea
Identifier Type: -
Identifier Source: org_study_id
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