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

Primary Purpose

Obstructive Sleep Apnea, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mandibular advancement device
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    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.

    This group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 24, 2018
    Last Updated
    May 16, 2018
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03517150
    Brief Title
    Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese
    Official Title
    Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 12, 2016 (Actual)
    Primary Completion Date
    May 19, 2018 (Anticipated)
    Study Completion Date
    June 12, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea, Obesity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    This group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group.
    Intervention Type
    Device
    Intervention Name(s)
    mandibular advancement device
    Primary Outcome Measure Information:
    Title
    Quality of life
    Description
    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.
    Time Frame
    10 minutes
    Title
    Daytime sleepiness
    Description
    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.
    Time Frame
    5 minutes
    Title
    Quality of sleep
    Description
    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.
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    Apnea-hypopnea index (AHI)
    Description
    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.
    Time Frame
    8 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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;

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Links:
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    Description
    American Academy of Sleep Medicine

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

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