NCT07367022

Portable Sleep Monitors in Children With Autism Spectrum Disorder

The Accuracy of Portable Sleep Monitoring for Children With Autism Spectrum Disorder

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Lena Xiao · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the ability of a portable sleep monitor to detect obstructive sleep apnea in children with autism spectrum disorder (ASD). The main study objectives are to: 1. Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG); 2. Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA); 3. Evaluate patient and family preferences for sleep testing.

Detailed description

Sleep disorders are highly prevalent in children with ASD, with as many as 80% of children reporting poor sleep. To identify the cause of poor sleep, many children will require a sleep study (polysomnogram; PSG), which is an overnight study done at the hospital using many different sensors to measure sleep and breathing. The PSG is the gold standard diagnostic test for obstructive sleep apnea (OSA) and measures the rate of obstructive respiratory events during sleep (obstructive apnea-hypopnea index; OAHI) which is crucial for treatment decision-making. However, PSGs are challenging for children with ASD due to the disrupted routine, burden and stress, and intolerance to the PSG setup. Further, diagnosis may be delayed up to 2 years due to a lack of pediatric sleep facilities in Canada, with pronounced geographical disparities. Although sleep disturbances are prevalent amongst children with ASD, there are significant inequities in accessing pediatric sleep medicine care and diagnostic testing. Alternative, simpler diagnostic testing is needed. We will evaluate a portable sleep monitor as the first step towards establishing home sleep apnea testing in children with ASD. We will conduct a feasibility study testing the Nox T3s portable sleep monitor alongside the traditional in-hospital polysomnogram to compare the ability of the Nox T3s to identify obstructive sleep apnea in children with ASD. We will also conduct qualitative interviews with families to gather insight on participant and family preferences for sleep testing to better address the needs of children with ASD.

Conditions

• Autism Spectrum Disorder (ASD)
• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DEVICE	Portable sleep monitor (Nox T3s)	Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Canada