Positional Therapy for Childhood Obstructive Sleep Apnoea

Obstructive Sleep Apnea Clinical Trial

Official title:

Positional Therapy for Childhood Obstructive Sleep Apnoea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453018
• Other study ID #: POSAv1.0
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Chinese University of Hong Kong
• Contact: Kate Ching Ching Chan, MD
• Phone: 35053515
• Email: katechan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Positional device, Rematee Bumper Belt
Positional device, Rematee Bumper Belt, Rematee, Blaine, Washington, will be used as the intervention

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstructive apnoea hypopnoea index with positional therapy	The change in the obstructive apnoea hypopnoea index between the baseline diagnostic polysomnography and the home sleep study using a positional device therapy	1 week
Secondary	Oxygen desaturation index with positional therapy	The changes in oxygen desaturation index between baseline polysomnography and the home sleep study using a positional device therapy	1 week
Secondary	Sleep symptoms	Questionnaire-based assessments on sleep symptoms by Pediatric Sleep Questionnaire	3 months
Secondary	Quality of life measure	Questionnaire-based assessments on quality of life measure by Obstructive Sleep Apnoea-18 (OSA-18) survey	3 months