Actively Recruiting
Positional Therapy for Childhood Obstructive Sleep Apnoea
Led by Chinese University of Hong Kong · Updated on 2025-02-14
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Positional Therapy for Childhood Obstructive Sleep Apnoea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6-17 years
- Diagnosis of positional OSA on a baseline diagnostic polysomnography (PSG), including moderate-to-severe OSA (OAHI ≥ 5 events/hour)
- Supine OAHI at least twice the non-supine OAHI
- At least 30 minutes or 10% total sleep time in both supine and non-supine positions on PSG
- Informed consent from a parent or legal guardian
You will not qualify if you...
- Severe OSA with OAHI ≥ 30 events/hour requiring other treatments before positional therapy
- Genetic, syndromal, or metabolic disease
- Congenital or acquired neuromuscular disease
- Craniofacial abnormalities
- Structural or congenital heart disease
- Severe chronic respiratory disease affecting oxygen or ventilation during sleep
- Autism spectrum disorder or severe developmental delay affecting device tolerance
- Current treatment with positive airway pressure
- Skeletal abnormalities or other conditions limiting sleeping positions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
K
Kate Ching Ching Chan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here