Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03517150|
Recruitment Status : Unknown
Verified May 2018 by Silvia de Carvalho Alvarenga, University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : May 7, 2018
Last Update Posted : May 21, 2018
University of Sao Paulo
Information provided by (Responsible Party):
Silvia de Carvalho Alvarenga, University of Sao Paulo
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Obesity||Device: mandibular advancement device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III|
|Actual Study Start Date :||May 12, 2016|
|Estimated Primary Completion Date :||May 19, 2018|
|Estimated Study Completion Date :||June 12, 2018|
Experimental: 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.
Device: mandibular advancement device
Active Comparator: Control group
This group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group.
Device: mandibular advancement device
Primary Outcome Measures :
- Quality of life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Outcome Measures :
- Apnea-hypopnea index (AHI) [ Time Frame: 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.
No Contacts or Locations Provided