Clinical trial NCT03821831: Treating Children With Obstructive Sleep Apnea After Surgery Failure
Official title: Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pediatric Obstructive Sleep Apnea
Pediatric Obesity
Keywords: Obstructive sleep apnea
Children
Orthodontic intervention
Nutrition
Metabolomic markers
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2019-01-30
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Measure of change in OSA severity
timeFrame: baseline and 12 months
measure: Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 12 months
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Change from baseline body mass index (BMI) at 12 months
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Faculty of Medicine and Dentistry
state: Alberta
Study officials:
affiliation: Dentistry, University of Alberta
name: Giseon Heo
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Respiratory Medicine, University of Alberta Hospital
name: Rochelle Young
role: STUDY_CHAIR
affiliation: Dentistry, University of Alberta
name: Paul Major
role: STUDY_DIRECTOR
References:
citation: 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.