Using positional therapy to treat childhood obstructive sleep apnea

Positional Therapy for Childhood Obstructive Sleep Apnoea

This study is testing if a special device can help children aged 6 to 17 with sleep apnea sleep better by encouraging them to sleep in different positions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06453018 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility and efficacy of positional therapy for children diagnosed with positional obstructive sleep apnea (OSA). The research focuses on children aged 6 to 17 years who experience obstructive respiratory events primarily while sleeping on their backs. Participants will use a positional device, such as the Rematee Bumper Belt or Night Shift, to potentially improve their sleep-related symptoms and overall quality of life. The study aims to determine if this non-invasive treatment strategy can effectively manage symptoms associated with positional OSA.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 17 years diagnosed with positional OSA based on specific polysomnography criteria.

Not a fit: Patients with severe OSA requiring more aggressive treatments, such as adenotonsillectomy or CPAP, or those with significant comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive treatment option that significantly improves sleep quality and health outcomes for children with positional OSA.

How similar studies have performed: While positional therapy is a recognized approach for managing positional OSA, the specific application in children is less explored, making this study a valuable contribution to the field.

Eligibility criteria

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

Where this trial is running

Hong Kong

• Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Kate Ching Ching Chan, MD — Chinese University of Hong Kong
• Study coordinator: Kate Ching Ching Chan, MD

Conditions: Obstructive Sleep Apnea