Portable Sleep Monitors in Children With Autism Spectrum Disorder

NCT07367022 | Recruiting

• 1 other identifier: H25-00532
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG);
2. 2.Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA);
3. 3.Evaluate patient and family preferences for sleep testing.

Conditions

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

Keywords

Portable Sleep Monitor; Polysomnogram; Children with ASD; Nox T3s; Sleep Disordered Breathing; Sleep disorder

Outcome Measures

Primary Outcomes (1)

• Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG)

  The OAHI measured from the portable sleep monitor will be compared to the OAHI measured from the PSG, the gold standard test for sleep-disordered breathing, to determine the ability of the portable sleep monitor to diagnose obstructive sleep apnea.

  Baseline

Secondary Outcomes (21)

• Patient and Family Preferences

  0-3 months after the baseline PSG

• Insomnia Questionnaire

  +/- 1 week from baseline PSG sleep test

• Chronotype Questionnaire

  +/- 1 week from baseline PSG sleep test

• Chronotype Questionnaire

  +/- 1 week from baseline PSG sleep test

• Chronotype Questionnaire

  +/- 1 week from baseline PSG sleep test

Study Arms (1)

Children with ASD testing a portable sleep monitor

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.

Device: Portable sleep monitor (Nox T3s)

Interventions

Portable sleep monitor (Nox T3s) DEVICE

Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.

Children with ASD testing a portable sleep monitor

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children who are undergoing a clinical PSG at British Columbia's Children's Hospital in Vancouver, Canada.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lena Xiao: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lena J Xiao, MD MSc

CONTACT

604-875-2345; lena.xiao@cw.bc.ca

Macyn LY Leung, MSc

CONTACT

604-875-2345; macyn.leung@bcchr.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: January 26, 2026
• Study Start: August 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CA (1)