NCT Number: NCT07367022
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.
Interested in participating?
Request Info6 year–18 year
All sexes
Observational
Vancouver, British Columbia, V6H 3N1, Canada
Location status: Recruiting
Lena J Xiao, MD MSc
CONTACT
604-875-2345 ext. 7606
Lena J Xiao, MD MSc
PRINCIPAL_INVESTIGATOR
Macyn LY Leung, MSc
CONTACT
604-875-2345 ext. 7606
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Lena J Xiao, MD MSc
CONTACT
604-875-2345 ext. 7606
Macyn LY Leung, MSc
CONTACT
604-875-2345 ext. 7606
Lena Xiao
Other
The Accuracy of Portable Sleep Monitoring for Children With Autism Spectrum Disorder
Acronym: PrSM
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