Treating Children With Obstructive Sleep Apnea After Surgery Failure

Terminated

• Conditions: Pediatric Obstructive Sleep Apnea; Pediatric Obesity
• Interventions: Device: Orthodontic intervention; Device: Continuous Positive Airway Pressure

• Registration Number: NCT03821831
• Lead Sponsor: University of Alberta

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-30
• Study Start: 2021-12-03
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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Exclusion Criteria

• Autism spectrum
• Down syndrome
• Pulmonary hypertension
• Cystic fibrosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orthodontic Intervention	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.
Continuous Positive Airway Pressure	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Faculty of Medicine and Dentistry; 🇨🇦 Edmonton, Alberta, Canada