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

January 16, 2026 updated by: Lena Xiao

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lena J Xiao, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG)
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Family Preferences
Time Frame: 0-3 months after the baseline PSG
Optional semi-structured qualitative interviews with caregivers and the patient, if they choose to and are capable of participating in the interviews. The interviews will be conducted virtually by a study team member to explore patient and family preferences and experiences with diagnostic sleep testing.
0-3 months after the baseline PSG
Insomnia Questionnaire
Time Frame: +/- 1 week from baseline PSG sleep test
The caregiver-reported Pediatric Insomnia Severity Index will be used to measure the severity of pediatric insomnia symptoms. Scores range from 0 to 30, with higher scores indicating greater insomnia severity.
+/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
Time Frame: +/- 1 week from baseline PSG sleep test
The caregiver-reported Children's Chronotype Questionnaire will measure the chronotype of the participant. The caregiver is given a short description of different chronotypes and selects the chronotype that best reflects their child's preference from a 5-point scale, ranging from "Definitely a Morning Type" = 1 to "Definitely an Evening Type" = 5.
+/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
Time Frame: +/- 1 week from baseline PSG sleep test
The Morningness/Eveningness Scale from the caregiver-reported Children's Chronotype Questionnaire will measure the participant's differences in activeness and alertness in the mornings and evenings. Scores range from 10-48, with scores indicating a morning type (≤ 23), intermediate type (24-32), and evening type (≥33).
+/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
Time Frame: +/- 1 week from baseline PSG sleep test
The sleep and wake parameters from the caregiver-reported Children's Chronotype Questionnaire will measure the participant's midsleep point on free days (MSF).
+/- 1 week from baseline PSG sleep test
Sleep Questionnaire
Time Frame: +/- 1 week from baseline PSG sleep test
The caregiver-reported Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorders subscale will measure the risk for sleep-related breathing disorders. The questionnaire contains 22-items scored as "yes" = 1 and "no" = 0 and normalized to the total number of questions answered, yielding a score between 0.0-1.0. Scores >0.33 indicate a high risk for sleep-related breathing disorders.
+/- 1 week from baseline PSG sleep test
Psychological Scale (Emotional Symptoms)
Time Frame: +/- 1 week from baseline PSG sleep test
The Emotional Symptoms subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater emotional difficulties.
+/- 1 week from baseline PSG sleep test
Psychological Scale (Conduct Problems)
Time Frame: +/- 1 week from baseline PSG sleep test
The Conduct Problems subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater conduct difficulties.
+/- 1 week from baseline PSG sleep test
Psychological Scale (Hyperactivity/inattention)
Time Frame: +/- 1 week from baseline PSG sleep test
The Hyperactivity/inattention subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater hyperactivity/inattention problems.
+/- 1 week from baseline PSG sleep test
Psychological Scale (Peer Relationship Problems)
Time Frame: +/- 1 week from baseline PSG sleep test
The Peer Relationship Problems subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating greater peer relationship problems.
+/- 1 week from baseline PSG sleep test
Psychological Scale (Pro-Social)
Time Frame: +/- 1 week from baseline PSG sleep test
The Pro-Social subscale of the Strengths and Difficulties Questionnaire will be used. The 5-item subscale score ranges from 0-10, with greater scores indicating less difficulty and an increased aptitude for kind and helpful behaviour.
+/- 1 week from baseline PSG sleep test
Psychological Scale (Total Difficulties)
Time Frame: +/- 1 week from baseline PSG sleep test
The Total Difficulties/Overall Stress scale of the Strengths and Difficulties Questionnaire will be calculated by totaling the following 4 subscales: emotional, conduct, hyperactivity, and peer relationships. The total score ranges from 0-40, with greater scores indicating greater difficulties and overall stress.
+/- 1 week from baseline PSG sleep test
Sensory Scale (Auditory Hypersensitivity)
Time Frame: +/- 1 week from baseline PSG sleep test
The Auditory Hypersensitivity subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 9-36, with greater scores indicating higher sensitivity for, and problems with, sounds related to auditory danger signals.
+/- 1 week from baseline PSG sleep test
Sensory Scale (Auditory Hyposensitivity to Voices)
Time Frame: +/- 1 week from baseline PSG sleep test
The Auditory Hyposensitivity to Voices subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 5-20, with greater scores indicating reduced sensitivity for speech or voices.
+/- 1 week from baseline PSG sleep test
Sensory Scale (Visual Hypersensitivity)
Time Frame: +/- 1 week from baseline PSG sleep test
The Visual Hypersensitivity subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 10-40, with greater scores indicating increased sensitivity to light and movement.
+/- 1 week from baseline PSG sleep test
Sensory Scale (Tactile Hypersensitivity)
Time Frame: +/- 1 week from baseline PSG sleep test
The Tactile Hypersensitivity subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 10-40, with greater scores indicating increased sensitivity to non-social touch.
+/- 1 week from baseline PSG sleep test
Sensory Scale (Affiliative Touch Aversion)
Time Frame: +/- 1 week from baseline PSG sleep test
The Affiliative Touch Aversion subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 3-12, with greater scores indicating increased negative response to social touch.
+/- 1 week from baseline PSG sleep test
Sensory Scale (Selective Eating)
Time Frame: +/- 1 week from baseline PSG sleep test
The Selective Eating subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 6-24, with greater scores indicating increased selectivity in food choices (i.e. picky eating).
+/- 1 week from baseline PSG sleep test
Sensory Scale (Ingestive Problems)
Time Frame: +/- 1 week from baseline PSG sleep test
The Ingestive Problems subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 3-12, with greater scores indicating increased problems with swallowing and retaining food.
+/- 1 week from baseline PSG sleep test
Sensory Scale (Digestive Problems)
Time Frame: +/- 1 week from baseline PSG sleep test
The Digestive Problems subscale of the Body Brain Center Sensory Scales will be used. The subscale score ranges from 4-16, with greater scores indicating increased problems with digestion.
+/- 1 week from baseline PSG sleep test
Autism Symptoms Dimensions Scale
Time Frame: +/- 1 week from baseline PSG sleep test
The caregiver-reported Autism Symptoms Dimensions Scale (ASDS) will be used to measure core autism symptoms in children and adolescents. The 39-item questionnaire is scored on a 5-point scale with total ASDS scores ranging from 39-195. Scores between 114-130 indicate high symptom levels and scores >130 indicate very high symptom levels.
+/- 1 week from baseline PSG sleep test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lena Xiao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H25-00532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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