Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric Obstructive Sleep Apnea
- Sponsor
- University of Alberta
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Measure of change in OSA severity
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change from baseline body mass index (BMI) at 12 months(baseline and 12 months)