Treating Children With Obstructive Sleep Apnea After Surgery Failure

NCT03821831 | Terminated FDA Device

• 1 other identifier: GHeo
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obstructive Sleep Apnea; Pediatric Obesity

Keywords

Obstructive sleep apnea; Children; Orthodontic intervention; Nutrition; Metabolomic markers

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change from baseline body mass index (BMI) at 12 months

  baseline and 12 months

Study Arms (3)

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

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

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.

Interventions

Continuous Positive Airway Pressure DEVICE

CPAP machine

Continuous Positive Airway Pressure

Orthodontic intervention DEVICE

Mandibular advancement or Rapid maxillary expansion devices

Orthodontic Intervention

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Autism spectrum
• Down syndrome
• Pulmonary hypertension
• Cystic fibrosis

Sponsors & Collaborators

• University of Alberta: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

Faculty of Medicine and Dentistry

Edmonton, Alberta, T6G 2R7, Canada

Location

Related Publications (1)

• 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.

  PMID: 35705345 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, blood and saliva

MeSH Terms

Conditions

Pediatric Obesity; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 30, 2019
• Study Start: December 3, 2021
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CA (1)