Positional Therapy for Childhood Obstructive Sleep Apnoea

NCT06453018 | Recruiting

• 1 other identifier: POSAv1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Sleep related symptoms

  Questionnaire-based assessments on sleep symptoms by Pediatric Sleep Questionnaire (PSQ): The PSQ consists of 22 items, and responses are scored as "yes" = 1, "no" = 0, and "don't know" = missing. The mean response on non-missing items is the score, which can range from 0 to 1. Higher scores on the PSQ indicate a greater likelihood of sleep-related problems. Specifically, a score greater than 0.33 (33% of questions answered positively) suggests a high risk for pediatric sleep-related breathing disorders

  3 months

• Daytime sleepiness assessment 1

  Questionnaire-based assessments on sleep symptoms by Pediatric Daytime Sleepiness Scale (PDSS): The PDSS consists of 8 questions, each scored on a 5-point Likert scale ranging from 0 to 4. Therefore, the total score can range from 0 to 32. Higher scores on the PDSS indicate greater daytime sleepiness.

  3 months

• Daytime sleepiness assessment 2

  Questionnaire-based assessments on sleep symptoms by modified Epworth Sleepiness Scale for children and adolescents (ESS-CHAD): The ESS-CHAD consists of 8 questions, each scored on a scale from 0 to 3. Therefore, the total score can range from 0 to 24. Higher scores on the ESS-CHAD indicate greater daytime sleepiness.

  3 months

Secondary Outcomes (3)

• Quality of life measure

  3 months

• Behavioural outcomes

  3 months

• Adherence to intervention

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Positional therapy

Device: Positional device, Rematee Bumper Belt or Night Shift

Interventions

Positional device, Rematee Bumper Belt or Night Shift DEVICE

Positional device, Rematee Bumper Belt (Rematee, Blaine, Washington), or Night Shift (Advanced Brain Monitoring) on chest belt, will be used as the intervention

Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-17 years
• 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)
• Informed consent from a parent or a legal guardian

You may not qualify if:

• 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
• Genetic, syndromal, or metabolic disease
• Congenital or acquired neuromuscular disease
• Craniofacial abnormalities
• Structural or congenital heart disease
• Severe chronic respiratory disease that may affect the oxygen saturation or ventilation during sleep and positional therapy is regarded as not appropriate
• 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
• Current treatment with positive airway pressure
• Skeletal abnormalities or other conditions that restrict the sleeping position

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kate Ching Ching Chan, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Ching Ching Chan, MD

CONTACT

35052839; katechan@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Children aged 6 to 17 years of age with positional OSA (POSA) will receive the positional therapy.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: June 11, 2024
• Study Start: July 3, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

HK (1)