Pediatric Obesity, Pediatric Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, Children, Orthodontic intervention, Nutrition, Metabolomic markers
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.
Interventions
DEVICEContinuous Positive Airway Pressure
CPAP machine
DEVICEOrthodontic intervention
Mandibular advancement or Rapid maxillary expansion devices
Sponsors
Natural Sciences and Engineering Research Council, Canada
University of Alberta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Outcome results
None listed