Autism Spectrum Disorder (ASD)PrSMNCT07367022
Portable Sleep Monitors in Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder (ASD) and Obstructive Sleep Apnea (OSA), run by Lena Xiao at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Obstructive Sleep Apnea (OSA)
- What is being tested?
- Portable sleep monitor (Nox T3s)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 12 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who are undergoing a clinical PSG at British Columbia's Children's Hospital in Vancouver, Canada.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
Lena J Xiao, MD MSc, 604-875-2345 ext. 7606, lena.xiao@cw.bc.ca
Macyn LY Leung, MSc, 604-875-2345 ext. 7606, macyn.leung@bcchr.ca
About this study
Official title: 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:
- Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG);
- Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA);
- Evaluate patient and family preferences for sleep testing.
Read the 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.
- Being tested
- Portable sleep monitor (Nox T3s)
- Keywords
- Portable Sleep Monitor, Polysomnogram, Children with ASD, Nox T3s, Sleep Disordered Breathing, Sleep disorder
- Medical subject headings
- Autism Spectrum Disorder, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable sleep monitor (Nox T3s)Device
Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Portable sleep monitor (Nox T3s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (21)
Patient and Family Preferences
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.
Measured: 0-3 months after the baseline PSG
Insomnia Questionnaire
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.
Measured: +/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
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.
Measured: +/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
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).
Measured: +/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
The sleep and wake parameters from the caregiver-reported Children's Chronotype Questionnaire will measure the participant's midsleep point on free days (MSF).
Measured: +/- 1 week from baseline PSG sleep test
Sleep Questionnaire
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.
Measured: +/- 1 week from baseline PSG sleep test
Psychological Scale (Emotional Symptoms)
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.
Measured: +/- 1 week from baseline PSG sleep test
Psychological Scale (Conduct Problems)
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.
Measured: +/- 1 week from baseline PSG sleep test
Psychological Scale (Hyperactivity/inattention)
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.
Measured: +/- 1 week from baseline PSG sleep test
Psychological Scale (Peer Relationship Problems)
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.
Measured: +/- 1 week from baseline PSG sleep test
Psychological Scale (Pro-Social)
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.
Measured: +/- 1 week from baseline PSG sleep test
Psychological Scale (Total Difficulties)
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.
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Auditory Hypersensitivity)
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.
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Auditory Hyposensitivity to Voices)
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.
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Visual Hypersensitivity)
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.
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Tactile Hypersensitivity)
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.
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Affiliative Touch Aversion)
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.
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Selective Eating)
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).
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Ingestive Problems)
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.
Measured: +/- 1 week from baseline PSG sleep test
Sensory Scale (Digestive Problems)
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.
Measured: +/- 1 week from baseline PSG sleep test
Autism Symptoms Dimensions Scale
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.
Measured: +/- 1 week from baseline PSG sleep test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start12 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lena Xiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lena Xiao, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367022
- Sponsor's protocol ID
- H25-00532
- Acronym
- PrSM
- Status last verified
- Jan 2026
- First submitted
- 17 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Portable Sleep Monitoring for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07367022
- Acronym / sponsor ID
- PrSM / H25-00532
- Keywords
- Portable Sleep Monitor, Polysomnogram, Children with ASD, Nox T3s, Sleep Disordered Breathing, Sleep disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lena XiaoUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG);
- Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA);
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with ASD testing a portable sleep monitor | – | Device: Portable sleep monitor (Nox T3s)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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who are undergoing a clinical PSG at British Columbia's Children's Hospital in Vancouver, Canada.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable sleep monitor (Nox T3s)Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram. | Device | Children with ASD testing a portable sleep monitor |
Primary outcome
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.
21 secondary outcomes
Patient and Family Preferences
Time frame: 0-3 months after the baseline PSG
Insomnia Questionnaire
Time frame: +/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
Time frame: +/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
Time frame: +/- 1 week from baseline PSG sleep test
Chronotype Questionnaire
Time frame: +/- 1 week from baseline PSG sleep test
Sleep Questionnaire
Time frame: +/- 1 week from baseline PSG sleep test
Psychological Scale (Emotional Symptoms)
Time frame: +/- 1 week from baseline PSG sleep test
Psychological Scale (Conduct Problems)
Time frame: +/- 1 week from baseline PSG sleep test
Psychological Scale (Hyperactivity/inattention)
Time frame: +/- 1 week from baseline PSG sleep test
Psychological Scale (Peer Relationship Problems)
Time frame: +/- 1 week from baseline PSG sleep test
Psychological Scale (Pro-Social)
Time frame: +/- 1 week from baseline PSG sleep test
Psychological Scale (Total Difficulties)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Auditory Hypersensitivity)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Auditory Hyposensitivity to Voices)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Visual Hypersensitivity)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Tactile Hypersensitivity)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Affiliative Touch Aversion)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Selective Eating)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Ingestive Problems)
Time frame: +/- 1 week from baseline PSG sleep test
Sensory Scale (Digestive Problems)
Time frame: +/- 1 week from baseline PSG sleep test
Autism Symptoms Dimensions Scale
Time frame: +/- 1 week from baseline PSG sleep test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder (ASD) and Obstructive Sleep Apnea (OSA), run by Lena Xiao at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena J Xiao, MD MSc (604-875-2345 ext. 7606, lena.xiao@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.