Longitudinal Associations Between Changes in Sleep Duration and Blood Pressure Across School Holiday in Sleep-deprived Teenagers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Change in ambulatory systolic blood pressure during wakefulness across school holidays
研究概览
简要总结
Our research question is: Are changes in sleep duration that occur naturally over school holidays associated with changes in blood pressure (BP) in sleep-deprived adolescents?
In this study, the investigators will take advantage of changes in sleep duration that occur during school holidays in adolescents who are sleep deprived (>6 months' history of sleeping <8 hours per night during school term). The investigators will monitor the changes in ambulatory BP and sleep duration over a period of 3 weeks which consist of a week at school, followed by a week of holiday when natural sleep extension takes place, and then another week of school after the holiday. Sleep-wake cycle will be recorded throughout the whole study period with actigraphy and sleep diary. Twenty-four hour ambulatory BP monitoring will be performed on the same weekday during each study week, when salivary cortisol will also be collected. The primary outcome measure is the difference in ambulatory BP parameters between school term and holiday. A control group without sleep deprivation (history of sleeping >8 hours per night) will also be studied concurrently
It is hypothesized that changes in sleep duration are negatively associated with changes in BP. If this study confirms our hypothesis, sleep extension can be used as a relatively inexpensive and simple behavioural intervention in the management and prevention of blood pressure abnormalities. More importantly positive results from this project will provide background information on which government and local school policy can be based and altered for the betterment of our youths.
详细描述
This is a cohort study that consists of 4 visits over a 3-week study period that includes two periods of 7-day school attendance and one period of 7-day school holiday (Study design flow chart). Subjects who have undergone physical examination and completed the screening questionnaire, and are found to meet all the inclusion and none of the exclusion criteria will be recruited. The first study week will be during school days, followed by a week of school holiday, and the final week is when the subject returns back to school after the holiday. The 3 periods need not to be consecutive so as to allow more flexibility to cater for the subjects' schedule. All assessments however have to be completed within 60 days to minimize the effects of growth on BP / sleep pattern.
Screening
During screening examination, participants will undergo a series of anthropometric measurements. The body build of the subject will be assessed using standard procedures. Standing height (in metres) will be measured without shoes using a Harpenden Stadiometer (Holtain, UK). Body weight will be measured by an electronic weighing scale (Tanita BF-522, Japan). Waist and hip circumference (in centimetres) will also be obtained. Body mass index and waist circumference will be converted into z score using local reference. Blood pressure will be taken using the Datascope Accutorr Plus. Two measurements are taken at 1-minute intervals, with a third reading taken 5 minutes later if the difference between the first two >4 mmHg. The average of two repeatable readings (difference ≤4 mmHg) will be used. Sexual maturity rating will be evaluated by a validated gender specific self-assessment questionnaire. Subjects will have to fill in a sleep questionnaire asking about their sleep habits and symptoms, pediatric daytime sleepiness scale (PDSS), Epworth sleepiness scale (ESS), and strength and difficulties questionnaire (SDQ). Information on parental medical history will also be obtained from the parents using a medical history questionnaire. The school calendar of each participant will also be obtained.
Collection of Data
Sleep pattern will be monitored by actigraphy together with sleep diary throughout the whole study period. Twenty four-hour ambulatory BP monitoring and neurocognitive tests will be performed on the last day of each study week. All BP monitoring and neurocognitive tests will be performed during weekdays instead of weekends to avoid the possible weekend effect on sleep pattern and outcomes. Saliva samples will also be collected in the evening and the morning when the subjects are wearing the BP monitor for assessing cortisol awakening response.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in ambulatory systolic blood pressure during wakefulness across school holidays
时间窗: From 1 week before holiday to 1 week after holidays, an average of 4 weeks.
Change in average systolic blood pressure during wakefulness as measured by 24-hour ambulatory blood pressure monitoring
次要结局
- Changes in other ambulatory BP parameters(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
- Change in visual-motor coordination(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
- Change in trail-making test score(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
- Change in sleep duration(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
- Change in impulsivity(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
- Change in Stroop test score(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
- Change in non-verbal reasoning(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
- Change in vigilance(From 1 week before holiday to 1 week after holidays, an average of 4 weeks.)
研究者
Albert Martin Li
Prof
Chinese University of Hong Kong