The Accuracy of Portable Sleep Monitoring for Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Portable sleep monitor (Nox T3s) (Device)
结局指标
主要结局
Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG)
时间窗: 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.
次要结局
- 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)
- Sleep Questionnaire(+/- 1 week from baseline PSG sleep test)
- Psychological Scale (Emotional Symptoms)(+/- 1 week from baseline PSG sleep test)
- Psychological Scale (Conduct Problems)(+/- 1 week from baseline PSG sleep test)
- Psychological Scale (Hyperactivity/inattention)(+/- 1 week from baseline PSG sleep test)
- Psychological Scale (Peer Relationship Problems)(+/- 1 week from baseline PSG sleep test)
- Psychological Scale (Pro-Social)(+/- 1 week from baseline PSG sleep test)
- Psychological Scale (Total Difficulties)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Auditory Hypersensitivity)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Auditory Hyposensitivity to Voices)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Visual Hypersensitivity)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Tactile Hypersensitivity)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Affiliative Touch Aversion)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Selective Eating)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Ingestive Problems)(+/- 1 week from baseline PSG sleep test)
- Sensory Scale (Digestive Problems)(+/- 1 week from baseline PSG sleep test)
- Autism Symptoms Dimensions Scale(+/- 1 week from baseline PSG sleep test)
研究者
Lena Xiao
Clinical Assistant Professor
University of British Columbia