Advancing Identification of Circadian Delay in ADHD Youth: Associations With Clinical Heterogeneity and Cognition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Circadian Rhythm (Sleep Timing)
研究概览
简要总结
The purpose of this study is to better understand sleep and circadian functioning in children with ADHD using home-based measures, parent report, and a lab based melatonin assessment. Investigators will also examine how sleep relates to psychiatric health and cognition among children with ADHD. The investigator for this study is Dr. Jessica Lunsford-Avery from the Department of Psychiatry.
详细描述
Participants will be asked to review and sign a consent form to enroll. As part of the study, participants will:
- Attend three study visits where they will be asked to complete questionnaires and assessments related to their child's attention and behavior, psychiatric health, and sleep habits. One of these visits is a lab-based melatonin assessment at night.
- Be asked to have their child wear a device (similar to a wrist watch) for a 7-day period. Parents will also be asked to complete an electronic daily diary about their child's sleep.
- Be asked to have their child wear a skin temperature sensor each evening after dinner until they wake up the next morning.
- Be asked to use a mattress sensor which measures movement, sleep state, and heart rate.
Participants will be compensated for their time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child ages 6-9
- •Meet criteria for a primary psychiatric diagnosis of DSM-5 ADHD, any presentation
- •Intellectual functioning >80
- •Healthy (i.e., no major medical problems)
- •If applicable, willingness to suspend use of melatonin during the study period
排除标准
- •Meet DSM-5 criteria for psychosis, bipolar, or autism spectrum disorders
- •Diagnosis of occult sleep disorders, including sleep apnea or restless leg syndrome
- •Medication for sleep other than melatonin
- •Plans to initiate stimulant medication during the study period
结局指标
主要结局
Circadian Rhythm (Sleep Timing)
时间窗: Nightly for 7 nights (at-home assessment)
Wearable sensor data collection includes 3 sensors and supporting materials. The GreenTEG Core sensor will measure changes in core body temperature (CBT) beginning each evening and continuing through the night until morning waking. The Withings Mat will index times in/out of bed and related sleep metrics. The Garmin Vivosmart 5 will continuously measure movement and heart rate.
DLMO - Dim Light Melatonin Onset
时间窗: Day 8 (second in-person study visit)
Salivary melatonin will be collected during an in-lab assessment, occurring on Friday night following the home assessment. Eleven saliva samples (\~2ml) will be collected in a darkened environment every 30 min for a period beginning 4 hours before the child's average weeknight bedtime and extending to 1 hour after their average weeknight bedtime as verified by the previous week's sleep diary. The time at which salivary melatonin concentrations exceed 4 pg/mL will be used for determining DLMO. Circadian alignment will be measured via phase angle calculation, or the duration of time between DLMO and average bedtime as recorded by (1) sleep diary and (2) average sleep onset (actigraphy).
次要结局
- Sleep disturbances as measured by parent report Children's Sleep Habits Questionnaire (CSHQ)(Immediately following the study period (up to approximately 2 weeks))
- Sleep routines as measured by the Pediatric Sleep Practices Questionnaire (PSPQ)(Immediately following the study period (up to approximately 2 weeks))
- Chronotype will be measured by parent report Children's Chronotype Questionnaire (CCTQ)(Immediately following the study period (up to approximately 2 weeks))