Positional Therapy for Childhood Obstructive Sleep Apnoea

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Positional device, Rematee Bumper Belt or Night Shift

• Registration Number: NCT06453018
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder associated with a wide spectrum of morbidities, including neurobehavioural, cardiovascular, and metabolic complications. Positional OSA (POSA) is one of the distinct clinical phenotypes in which obstructive respiratory events occur predominantly while sleeping in the supine position. As the majority of the OSA events in POSA occur in the supine position, positional therapy has become a reasonable non-invasive treatment strategy.

The primary objectives of our study are 1) To investigate the feasibility of positional therapy in children with positional OSA; 2) To investigate the efficacy of positional therapy in children with positional OSA.

Hypothesis to be tested: 1) Positional therapy is feasible in children with positional OSA.

2) Positional therapy is efficacious in children with positional OSA by improving sleep related symptoms and quality of life.

Design and subjects: A prospective case-control study. 20 children aged 6 to 17 years of age with positional OSA (POSA) will be invited to join the study.

Primary and secondary outcome measures: The changes in sleep-related symptoms, quality of life and behavioral measures between the baseline and 3 months after treatment with a positional device therapy. Adherence to the positional device.

Statistical Analysis: Continuous data will be presented as mean and standard deviation or median with the interquartile range depending on its distribution, whereas categorical data will be shown as proportions. Changes in outcome measures between the baseline and 3 months after using the positional device will be compared using Wilcoxon signed rank tests. Within-subject differences in the outcome parameters will be tested by paired t-tests, McNemar tests, and marginal homogeneity tests for continuous, dichotomous, and categorical data respectively.

Expected results: Positional therapy is practicable and efficacious in children with positional OSA by improving sleep related symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-11
• Status Verified: 2024-07
• Study Start: 2024-07-03
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 6-17 years
2. Diagnosis of positional OSA on a baseline diagnostic polysomnography (PSG), defined as 1) an overall OAHI ≥ 5 events/hour (moderate-to-severe OSA), 2) a supine OAHI greater than or equal to two times of the non-supine OAHI, and 3) at least 30 minutes or 10% of total sleep time of supine sleep, and at least 30 minutes or 10% of total sleep time of non-supine sleep observed in the diagnostic PSG (9-11)
3. Informed consent from a parent or a legal guardian

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Exclusion Criteria

1. Severe OSA with an OAHI ≥ 30 events/hour that conventional treatment such as adenotonsillectomy and CPAP should be considered before positional therapy, severe disease warranting urgent referral for treatment
2. Genetic, syndromal, or metabolic disease
3. Congenital or acquired neuromuscular disease
4. Craniofacial abnormalities
5. Structural or congenital heart disease
6. Severe chronic respiratory disease that may affect the oxygen saturation or ventilation during sleep and positional therapy is regarded as not appropriate
7. Autism spectrum disorder or severe developmental delay (developmental or functional age <66% of chronological age (16) that could affect the tolerance to the positional device
8. Current treatment with positive airway pressure
9. Skeletal abnormalities or other conditions that restrict the sleeping position

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Positional device, Rematee Bumper Belt or Night Shift	Positional therapy

Primary Outcome Measures

Name	Time	Method
Sleep related symptoms	3 months	Questionnaire-based assessments on sleep symptoms by Pediatric Sleep Questionnaire
Daytime sleepiness assessment 1	3 months	Questionnaire-based assessments on sleep symptoms by Pediatric Daytime Sleepiness Scale
Daytime sleepiness assessment 2	3 months	Questionnaire-based assessments on sleep symptoms by Epworth Sleepiness Scale

Secondary Outcome Measures

Name	Time	Method
Behavioural outcomes	3 months	Questionnaire-based assessments on behavioural outcomes using child behavior checklist CBCL
Adherence to intervention	3 months	Diary-based assessments on adherence or device recorded usage if using Night Shift
Quality of life measure	3 months	Questionnaire-based assessments on quality of life measure by Obstructive Sleep Apnoea-18 questionnaire

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong