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

Obesity Clinical Trial

Official title:

Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03517150
• Other study ID #: FOB apnea
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2016
• Est. completion date: June 12, 2018

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 12, 2018
• Est. primary completion date: May 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• mandibular advancement device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	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.	10 minutes
Primary	Daytime sleepiness	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.	5 minutes
Primary	Quality of sleep	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.	5 minutes
Secondary	Apnea-hypopnea index (AHI)	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.	8 hours

External Links

•   American Academy of Sleep Medicine