Treating Children With Obstructive Sleep Apnea After Surgery Failure

January 26, 2024 updated by: University of Alberta

Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R7
        • Faculty of Medicine and Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Continuous Positive Airway Pressure
CPAP machine
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.
Device: Orthodontic intervention
Mandibular advancement or Rapid maxillary expansion devices
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of change in OSA severity
Time Frame: baseline and 12 months
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
Time Frame: baseline and 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
Time Frame: baseline and 12 months
Height (m) and weight (kg) will be measured to calculate BMI (kg/m^2).
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Natural Sciences and Engineering Research Council, Canada

Investigators

  • Principal Investigator: Giseon Heo, Dentistry, University of Alberta
  • Study Chair: Rochelle Young, Pediatric Respiratory Medicine, University of Alberta Hospital
  • Study Director: Paul Major, Dentistry, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2021

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHeo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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