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

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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
Sponsor:
Information provided by (Responsible Party):
Silvia de Carvalho Alvarenga, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Obesity Device: mandibular advancement device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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 :
  1. 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.

  2. 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.

  3. 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 :
  1. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Additional Information:
Publications of Results:
Other Publications:
Almeida FR, Dal-Fabbro C, Chaves Jr CM. Síndrome da apneia e hipopneia obstrutiva do sono (SAHOS): tratamento com aparelhos intra-orais. In: Tufik, S. Medicina e biologia do sono.1ª ed. São Paulo: Manole; 2008. p. 263-80.
Sutherland K, Phillips CL, Cistulli PA (2015) Efficacy versus effectiveness in the treatment of obstructive sleep apnea: CPAP and oralappliances.J Dent Sleep Med2:175-181.10.15331/jdsm.5120

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Responsible Party: Silvia de Carvalho Alvarenga, principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03517150    
Other Study ID Numbers: FOB apnea
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases