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

NCT03517150 | Unknown

• 1 other identifier: FOB apnea
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea; Obesity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Apnea-hypopnea index (AHI)

  8 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

mandibular advancement device DEVICE

Control group; Experimental group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

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Related Links

• American Academy of Sleep Medicine

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 7, 2018
• Study Start: May 12, 2016
• Primary Completion: May 19, 2018
• Study Completion: June 12, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share