Treating Children With Obstructive Sleep Apnea After Surgery Failure

Pediatric Obesity Clinical Trial

Official title:

Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03821831
• Other study ID #: GHeo
• Status: Terminated
• Start date: December 3, 2021
• Est. completion date: May 8, 2023

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Pediatric Obesity
• Pediatric Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
CPAP machine
• Orthodontic intervention
Mandibular advancement or Rapid maxillary expansion devices

Locations

Country	Name	City	State
Canada	Faculty of Medicine and Dentistry	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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