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Treating Children With Obstructive Sleep Apnea After Surgery Failure

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821831
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Natural Sciences and Engineering Research Council, Canada
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief Summary:
The aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (CPAP), versus no treatment.

Condition or disease Intervention/treatment
Pediatric Obstructive Sleep Apnea Pediatric Obesity Device: Continuous Positive Airway Pressure Device: Orthodontic intervention

Detailed Description:
Consenting patients and their parents will choose one of three options (within the context of medical/craniofacial appropriateness): CPAP, orthodontic intervention, or to remain untreated (control). It would be ideal if each patient was randomly assigned to one of three groups. However, in our study, random allocation is not an option as the established clinical pathways for treatment, financial resources, and physiological presentation of the patient determines the appropriate intervention. In each group, the effectiveness of the intervention will be analyzed through the evaluation of sleep parameters, medical history, questionnaire responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and at 12 months.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort Intervention/treatment
Continuous Positive Airway Pressure
This group consists of consenting patients and their parents who choose Continuous Positive Airway Pressure (CPAP). The CPAP is a type of therapy that applies mild air pressure to a person's upper airway to keep their airway open so that they can breathe normally while they sleep.
 Device: Continuous Positive Airway Pressure
CPAP machine
Orthodontic Intervention
This group consists of consenting patients and their parents who choose orthodontic intervention will be seen by participating orthodontists who will determine types of orthodontic intervention; mandibular advancement devices or rapid maxillary expansion devices. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study.
 Device: Orthodontic intervention
Mandibular advancement or Rapid maxillary expansion devices
Control
This group consists of consenting patients and their parents who choose to remain untreated. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study.


Outcome Measures
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Primary Outcome Measures :
  1. Measure of change in OSA severity [ Time Frame: baseline and 12 months ]
    Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months

  2. Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 12 months [ Time Frame: baseline and 12 months ]
    PSQ consists of total 22 questions with choices of answer; Yes or No. Yes answer will be coded as 1 and No answer coded as 0. Sum of 22 questions will be compared.


Secondary Outcome Measures :
  1. Change from baseline body mass index (BMI) at 12 months [ Time Frame: baseline and 12 months ]
    Height (m) and weight (kg) will be measured to calculate BMI (kg/m^2).


Biospecimen Retention:   Samples Without DNA
Urine, blood and saliva

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children from 6 to16 years old, from both sexes in Alberta, Canada, diagnosed with (a) residual OSA (post-T&A) or (b) diagnosed with OSA but for whom T&A is not a treatment option.
Criteria

Inclusion Criteria:

  • Patients diagnosed with obstructive sleep apnea by polysomnography who presented with a failure in treatment with surgical removal of the tonsils and adenoid tissue --adenotonsillectomy (T&A).
  • Patients diagnosed with obstructive sleep apnea but for whom T&A was not an option following assessment by Otolaryngology.

Exclusion Criteria:

  • Autism spectrum
  • Down syndrome
  • Pulmonary hypertension
  • Cystic fibrosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821831


Contacts
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Contact: Giseon Heo 1-780-492-1332 gheo@ualberta.ca
Contact: Rochelle Young 1-780-407-2977 Rochelle.Young@albertahealthservices.ca

Locations
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Canada, Alberta
Faculty of Medicine and Dentistry
Edmonton, Alberta, Canada, T6G 2R7
Contact: Rochelle Young    1-780-407-2977    Rochelle.Young@albertahealthservices.ca   
Contact: Dory Sample    1-780-248-5599    Dory.Sample@albertahealthservices.ca   
Principal Investigator: Rochelle Young         
Principal Investigator: Carlos Flores-Mir         
Sub-Investigator: Manuel Lagravere         
Sub-Investigator: Paul Major         
Sub-Investigator: Michael Major         
Principal Investigator: Diana Mager         
Sponsors and Collaborators
University of Alberta
Natural Sciences and Engineering Research Council, Canada
Investigators
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Principal Investigator: Giseon Heo Dentistry, University of Alberta
Study Chair: Rochelle Young Pediatric Respiratory Medicine, University of Alberta Hospital
Study Director: Paul Major Dentistry, University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03821831    
Other Study ID Numbers: GHeo
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Alberta:
Obstructive sleep apnea
Children
Orthodontic intervention
Nutrition
Metabolomic markers
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pediatric Obesity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight