Sleep Promotion Among Children Newly Diagnosed With Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Hypertension
研究概览
简要总结
Determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting, to increase sleep duration and reduce systolic and diastolic blood pressure.
详细描述
Insufficient sleep is associated with hypertension in children. Despite this knowledge, sleep promotion is not considered as a behavioral target during the initial treatment of pediatric essential hypertension. Investigators are developing a mobile platform to promote sleep in children that may have utility for treating pediatric essential hypertension.
The overall objective of this study is to determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting, to increase sleep duration and reduce systolic and diastolic blood pressure.
This is a home-based, single-site study, of 13-to-18-year-olds (N=10, 5 parent-child dyads). Participants will have a recent diagnosis of essential hypertension, based on clinical ambulatory blood pressure monitoring, with initial treatment targeting lifestyle modification without pharmacological therapy. Participants must have cellular or internet access and spend less than or equal to 7.5 hours in bed per night. Children will be excluded if they have a known clinical sleep disorder.
The sleep promotion intervention will be delivered using REDCap. All participants will be provided with a sleep tracker to monitor their sleep patterns throughout the study. A two-week run-in phase will be used to capture baseline sleep patterns, and a home sleep polysomnography test will be completed to provide clinical sleep data. During a 7-week intervention phase, all participants will receive the same intervention condition. Participants will be provided a sleep duration goal paired with a loss-framed financial incentive (virtual account) starting with deductions each time the sleep goal is not met, will be sent sleep guidance text messages, and will receive weekly performance feedback text messages. Further, at the end of the intervention phase, participants will undergo a second Ambulatory Blood Pressure Monitoring (ABPM). The primary outcome is acceptance and feasibility of completing this study captured via self-reported feedback and documenting compliance with the study protocol. The secondary outcomes are changes in sleep duration from baseline, and changes in daytime and nocturnal systolic and diastolic blood pressure from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Speak, read and write in English.
- •Parental/guardian permission (informed consent) and child assent.
- •Have a computer or a tablet computer with access to the Internet or own a smartphone with a data and text plan.
- •Parent reported sleep duration on school nights less than or equal to 7.5 hours.
- •Recently diagnosed with essential hypertension by Ambulatory Blood Pressure Monitoring (ABPM).
- •If taking over the counter sleep aides, willing to stop them over the course of the study.
排除标准
- •Any clinically diagnosed sleep disorder (e.g. sleep apnea) in the electronic health record and or regular use of prescribed sleep aide.
- •Underlying chronic medical conditions, defined as a medical condition with a duration or expected duration longer than 3 months that involved taking regular medication, taking medications that could affect blood pressure (e.g., anti-hypertensive medications, glucocorticoids, or stimulants), and patients with underlying diagnoses known to be associated with elevated blood pressure (e.g., cardiac disease, kidney disease or diabetes).
- •Inclusion Criteria for Parents/Legal Guardians:
- •Be the parent/guardian of an eligible child enrolled in the main study.
- •Speak, read, and write in English.
- •Exclusion Criteria for Parents/Legal Guardians:
- •- Limited English proficiency
研究组 & 干预措施
Arm 1
Sleep goal, Sleep guidance messaging, Loss-framed incentive, Supportive feedback.
干预措施: Intervention (Behavioral)
结局指标
主要结局
Hypertension
时间窗: From baseline to approximately week 11
The number of participants who are still diagnosed with hypertension by ambulatory blood pressure monitoring (ABPM). This is defined as a mean systolic or diastolic blood pressure when either awake or asleep, greater than the 95th percentile.
Change in sleep tracker estimated weeknight sleep duration
时间窗: From baseline to approximately week 11
Change in sleep tracker estimated weeknight sleep duration will be measured from baseline (operationalized as the average hours per weeknight per week). There will be one week of baseline data and seven weeks of intervention data as well as two weeks of follow-up data.
次要结局
- Change in sleep tracker estimated sleep duration(From baseline to approximately week 11)
- Changes in sleep disturbance score measured by the Patient-Reported Outcome Measurement System (PROMIS) tool(From baseline to approximately week 11)
- Change in daytime systolic/diastolic blood pressures as measured by Ambulatory Blood Pressure Monitoring (ABPM)(From baseline to approximately week 11)
- Change in night time systolic/diastolic blood pressures as measured by ABPM(From baseline to approximately week 11)