Obesity, Obstructive Sleep Apnea
Conditions
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.
Interventions
DEVICEmandibular advancement device
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 10 minutes | The Short-Form 36-Item Health Survey (SF-36) will be used to measure quality of life. This instrument will evaluate the physical health component (PHC) and the mental health component (MHC) through the following dimensions: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health. |
| Daytime sleepiness | 5 minutes | The Epworth sleepiness scale (ESS) wil measure the subjective daytime sleepiness, assesses the propensity to sleep under inappropriate circumstances. The ESS questionnaire consists of 8 questions about daytime sleepiness in various situations. |
| Quality of sleep | 5 minutes | The Pittsburgh Sleep Quality Index is the instrument deployed to evaluate the subjective quality of sleep and the presence of possible disorders. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The score is determined by the sum of the seven components, with each answer being given a score between 0 and 3 points. The maximum score of the instrument is 21. The scores\> 5 points indicate poor quality in the sleep pattern. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea index (AHI) | 8 hours | The obstructive Apnea-hypopnea Index is defined as the mean number of obstructive apneas and hypopneas per hour of sleep, thus: the occurrence of 5 to 14 events per hour of sleep means presence of mild apnea, 15 to 29 moderate apnea and ≥ 30 severe apnea. The AHI is derived from overnight polysomnography. |
Outcome results
None listed