Treating Children With Obstructive Sleep Apnea After Surgery Failure

Study 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.

Official Title
-----------------
Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap

Conditions
-----------------
Pediatric Obstructive Sleep Apnea, Pediatric Obesity

Intervention / Treatment
-----------------
* Device: Continuous Positive Airway Pressure
* Device: Orthodontic intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Continuous Positive Airway Pressure<br>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<br>* CPAP machine<br>|
| Orthodontic Intervention<br>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<br>* Mandibular advancement or Rapid maxillary expansion devices<br>|
| Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of change in OSA severity | Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months | 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. | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline body mass index (BMI) at 12 months | Height (m) and weight (kg) will be measured to calculate BMI (kg/m^2). | baseline and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea, Children, Orthodontic intervention, Nutrition, Metabolomic markers