Treating Children With Obstructive Sleep Apnea After Surgery Failure

Sponsor

University of Alberta (Other)

Overall Status

Recruiting

CT.gov ID

NCT03821831

Collaborator

Natural Sciences and Engineering Research Council, Canada (Other)

100

Enrollment

Location

59.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap

Actual Study Start Date :

Dec 3, 2021

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	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, or Class III mid face advancement with skeletal anchored headgear. 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.

Arm

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, or Class III mid face advancement with skeletal anchored headgear. 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

Primary Outcome Measures

Measure of change in OSA severity [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 [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine and Dentistry	Edmonton	Alberta	Canada	T6G 2R7

Sponsors and Collaborators

University of Alberta
Natural Sciences and Engineering Research Council, Canada

Investigators

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