Positional Therapy for Childhood Obstructive Sleep Apnoea

Status Recruiting

Clinical Trial 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 reducing the severity of the OSA as measured by the obstructive apnoea hypopnoea index. 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 outcome measures: Feasibility of the use of positional device therapy; the change in the OAHI between the baseline diagnostic PSG and the home sleep study using a positional device therapy. 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 sleep study parameters between the baseline PSG and the home sleep study using the positional device will be compared using Wilcoxon signed rank tests. Within-subject differences in the secondary 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 reducing the severity of the OSA.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06453018
Study type	Interventional
Source	Chinese University of Hong Kong
Contact	Kate Ching Ching Chan, MD
Phone	35053515
Email	katechan@cuhk.edu.hk
Status	Recruiting
Phase	N/A
Start date	June 1, 2024
Completion date	December 31, 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.