Treating Children With Obstructive Sleep Apnea After Surgery Failure
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|ClinicalTrials.gov Identifier: NCT03821831|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment|
|Pediatric Obstructive Sleep Apnea Pediatric Obesity||Device: Continuous Positive Airway Pressure Device: Orthodontic intervention|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
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
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
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.
- 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
- 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.
- 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
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
|Contact: Giseon Heofirstname.lastname@example.org|
|Contact: Rochelle Young||1-780-407-2977||Rochelle.Young@albertahealthservices.ca|
|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|
|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|