Treating Children With Obstructive Sleep Apnea After Surgery Failure

University of Alberta8 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Pediatric Obstructive Sleep Apnea Pediatric Obesity

Interventions

Continuous Positive Airway PressureDEVICE

CPAP machine

Orthodontic interventionDEVICE

Mandibular advancement or Rapid maxillary expansion devices

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine and Dentistry

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Measure of change in OSA severity

Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months

Time frame: baseline and 12 months

Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 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.

Time frame: baseline and 12 months

Secondary Outcomes

Change from baseline body mass index (BMI) at 12 months

Height (m) and weight (kg) will be measured to calculate BMI (kg/m\^2).

Time frame: baseline and 12 months

Data from ClinicalTrials.gov

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