Nocturnal Hypertension and Sleep (Sleep BP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
研究概览
简要总结
The purpose of this study is to examine the impact that sleep duration has on blood pressure (BP) levels during sleep. The investigator will examine the effect of an 8-week sleep hygiene/extension intervention vs. control on sleep BP.
详细描述
Short sleep duration (SSD), defined as sleeping less than 7 hours per night, affects over 33% of US adults and is associated with increased mortality. SSD is a modifiable risk factor for obesity, type 2 diabetes, and HTN. Cross-sectional studies have demonstrated that SSD is associated with higher sleep BP levels. SSD is also associated with non-dipping BP which is primarily explained by higher sleep BP levels. However, many of the cross-sectional studies have included adolescent participants or have not used reference standard measures of sleep duration such as wrist actigraphy. Manipulating sleep duration experimentally through sleep restriction or deprivation is associated with higher 24-hour and sleep BP levels. In contrast, there is scarce data on the effect of sleep extension on sleep BP levels among adults with SSD.
Eligible community individuals with short sleep duration will be randomized to sleep extension vs. control using 24-hour ambulatory blood pressure monitoring (ABPM) and actigraphy in the naturalistic environment. Individuals will be assessed throughout the study using questionnaires, activity monitoring via a Fitbit device (for 8 weeks), blood pressure monitoring using a 24-hour ABPM device, and heart rate variability monitoring for 24-hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized in a 1:1 ratio to each arm by a computer-generated random allocation sequence. All study investigators and outcome assessors will be blinded to group assignment and will not have access to the randomization sequence. The Educational Research Coordinator who will deliver the educational sessions will be unblinded to treatment arm but will not be involved in collecting study measures or data analyses.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking adults
- •Age 18 and older
- •Sleep duration < 7 hours per night as assessed via daily self-report of sleep hours
排除标准
- •Inability to read or write in English
- •Pregnant or plans to get pregnant within study period
- •Arm circumference >50 cm
- •Lymphedema of the arm or unable to wear ABPM device for 24 hours or wrist actigraphy for 8 weeks
- •End-stage renal disease (ESRD) on dialysis
- •Unreliable internet or phone/text access
- •High risk of Obstructive Sleep Apnea (OSA) (using the Berlin Questionnaire or diagnosis of OSA or use continuous positive airway pressure device)
- •High risk of insomnia (using the Insomnia Severity Index), or a known prior history of insomnia, and/or use of prescription sleep aides
- •High risk of depression (using the Patient Health Questionnaire Depression Scale: PHQ-8)
- •Perimenopausal women who have hot flashes (using the Menopause Rating Scale (MRS) questionnaire, administered only to females age 45-65)
- •Plan to travel out of state and/or internationally during the study period
研究组 & 干预措施
Sleep Hygiene/Extension Intervention
Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
干预措施: Sleep hygiene/extension intervention (Behavioral)
Control Condition
Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.
干预措施: Control care (Behavioral)
结局指标
主要结局
Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 Weeks
时间窗: Baseline, 8 weeks
Mean of valid BP readings during the sleep period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean sleep diastolic BP (mmHg) at baseline and 8 weeks.
Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks
时间窗: Baseline, 8 weeks
Mean of valid BP readings during the sleep period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean sleep systolic BP (mmHg) at baseline and 8 weeks.
次要结局
- Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 Weeks(Baseline, 8 weeks)
- Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 Weeks(Baseline, 8 weeks)
- Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 Weeks(Baseline, 8 weeks)
- Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 Weeks(Baseline, 8 weeks)
- 24-hour High Frequency Heart Rate Variability(Baseline, 8 weeks)
研究者
Marwah Abdalla
Associate Professor of Medicine
Columbia University