Clinical trial NCT03517150: Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese
Official title: Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

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;

Primary outcomes:
measure: Quality of life
timeFrame: 10 minutes
measure: Daytime sleepiness
timeFrame: 5 minutes
measure: Quality of sleep
timeFrame: 5 minutes
Secondary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: 8 hours
Other outcomes:
Locations:
Study officials:
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