NCT03821831

Treating Children With Obstructive Sleep Apnea After Surgery Failure

Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Obstructive Sleep Apnea
• Pediatric Obesity

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure	CPAP machine
DEVICE	Orthodontic intervention	Mandibular advancement or Rapid maxillary expansion devices

Timeline

• Start date: 2021-12-03
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2019-01-30
• Last updated: 2024-01-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study