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COVID hindered enrollment
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| Name | Class |
|---|---|
| Natural Sciences and Engineering Research Council, Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Control | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | CPAP machine |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children from 6 to16 years old, from both sexes in Alberta, Canada, diagnosed with (a) residual OSA (post-T&A) or (b) diagnosed with OSA but for whom T&A is not a treatment option.
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| Name | Affiliation | Role |
|---|---|---|
| Giseon Heo | Dentistry, University of Alberta | Principal Investigator |
| Rochelle Young | Pediatric Respiratory Medicine, University of Alberta Hospital | Study Chair |
| Paul Major | Dentistry, University of Alberta | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine and Dentistry | Edmonton | Alberta | T6G 2R7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35705345 | Derived | Fagundes NCF, Perez-Garcia A, Graf D, Flores-Mir C, Heo G. Orthodontic interventions as a management option for children with residual obstructive sleep apnea: a cohort study protocol. BMJ Open. 2022 Jun 15;12(6):e061651. doi: 10.1136/bmjopen-2022-061651. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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Urine, blood and saliva
| Orthodontic intervention |
| Device |
Mandibular advancement or Rapid maxillary expansion devices |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |