Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese

University of Sao Paulo

Status: Unknown

Conditions: Obesity; Obstructive Sleep Apnea

Treatments: Device: mandibular advancement device

Study type: Interventional

Funder types: Other

Identifiers

NCT03517150

FOB apnea

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Device: mandibular advancement device

Control group

Active Comparator group

Description:

This group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group.

Treatment:

Device: mandibular advancement device