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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable sleep monitor (Nox T3s) | Device | Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-3 months after the baseline PSG |
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Inclusion Criteria:
Exclusion Criteria:
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Children who are undergoing a clinical PSG at British Columbia's Children's Hospital in Vancouver, Canada.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lena J Xiao, MD MSc | Contact | 604-875-2345 | 7606 | lena.xiao@cw.bc.ca |
| Macyn LY Leung, MSc | Contact | 604-875-2345 | 7606 | macyn.leung@bcchr.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Children's Hospital | Recruiting | Vancouver | British Columbia | V6H 3N1 | Canada |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001049 | Apnea |
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| 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. | +/- 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. | +/- 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). | +/- 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). | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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. | +/- 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). | +/- 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. | +/- 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. | +/- 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. | +/- 1 week from baseline PSG sleep test |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |