Treating Children With Obstructive Sleep Apnea After Surgery Failure

University of Alberta

Status: Terminated

Conditions: Pediatric Obstructive Sleep Apnea; Pediatric Obesity

Treatments: Device: Continuous Positive Airway Pressure; Device: Orthodontic intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03821831

GHeo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 3 patient groups

Continuous Positive Airway Pressure

Description:

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.

Treatment:

Device: Continuous Positive Airway Pressure

Orthodontic Intervention

Description:

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.

Treatment:

Device: Orthodontic intervention

Control

Description:

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.