Portable Sleep Monitors in Children With Autism Spectrum Disorder (PrSM)

Lena Xiao

Status: Enrolling

Conditions: Obstructive Sleep Apnea (OSA); Autism Spectrum Disorder (ASD)

Treatments: Device: Portable sleep monitor (Nox T3s)

Study type: Observational

Funder types: Other

Identifiers

NCT07367022

H25-00532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children between 6 to 18 years of age, AND;
2. Children diagnosed with autism spectrum disorder, AND;
3. Children who will be undergoing a polysomnogram (PSG) for the first time, AND;
4. Caregiver willing to complete questionnaires about child's sleep and behavior

Exclusion criteria

1. Children who are currently using respiratory therapy
2. Children who have previously completed a PSG
3. Caregiver unwilling to complete questionnaires about child's sleep and behavior

Trial design

20 participants in 1 patient group

Children with ASD testing a portable sleep monitor

Description:

Children aged 6-18 years old with autism spectrum disorder concurrently testing a portable sleep monitor (Nox T3s) during their first clinical polysomnogram. Children and their caregivers may also complete a qualitative interview about sleep testing preferences after their sleep test.

Treatment:

Device: Portable sleep monitor (Nox T3s)