Positional Therapy for Childhood Obstructive Sleep Apnoea

Last updated: February 12, 2025
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Positional device, Rematee Bumper Belt

Positional device, Rematee Bumper Belt or Night Shift

Clinical Study ID

NCT06453018
POSAv1.0
  • Ages 6-17
  • All Genders

Study 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.

  1. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 6-17 years

  2. Diagnosis of positional OSA on a baseline diagnostic polysomnography (PSG), definedas 1) an overall OAHI ≥ 5 events/hour (moderate-to-severe OSA), 2) a supine OAHIgreater than or equal to two times of the non-supine OAHI, and 3) at least 30minutes 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

Exclusion

Exclusion Criteria:

  1. Severe OSA with an OAHI ≥ 30 events/hour that conventional treatment such asadenotonsillectomy and CPAP should be considered before positional therapy, severedisease 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 orventilation during sleep and positional therapy is regarded as not appropriate

  7. Autism spectrum disorder or severe developmental delay (developmental or functionalage <66% of chronological age (16) that could affect the tolerance to the positionaldevice

  8. Current treatment with positive airway pressure

  9. Skeletal abnormalities or other conditions that restrict the sleeping position

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Positional device, Rematee Bumper Belt
Phase:
Study Start date:
July 03, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

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