Sleep Restriction and Parental History of Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 24-hour Systolic Blood Pressure (BP)
研究概览
简要总结
The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood pressure compared to a group of individuals whose parents have normal blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-35 years
- •Absence of any significant medical or psychiatric disease (as per the investigators' judgment)
- •Nonsmoker
- •Nonpregnant
- •History of normal sleep duration (reported average sleep duration between 7-9 hours/night and no habitual napping)
- •Hypertension status information available for both biological parents
- •Ability to understand study procedures and to comply with them for the entire length of the study
- •Ability to understand English and provide informed consent
排除标准
- •Age <18 or >35 years
- •Body mass index <18.5 or ≥30 kg/m2
- •Pregnant or lactating
- •Unable to determine history of HTN in participant's biological parents or subject being adopted
- •Use of tobacco, vaping, marijuana products or other drugs
- •Excessive caffeine consumption (>400 mg/day)
- •Excessive alcohol consumption (>7 drinks/week for women, >14 drinks/week for men)
- •Office SBP/DBP ≥130/80 mmHg
- •Daytime ambulatory SBP/DBP ≥130/80 mmHg
- •Fasting glucose ≥126 mg/dl
- •Glomerular filtration rate <60 mL/min/BSA
- •History of significant medical or psychiatric disorders (as per the investigators' judgment)
- •Regular use of prescription medications other than contraceptives
- •Use of melatonin supplements or any other over-the-counter sleep aid
- •Moderate-to-severe sleep disordered breathing (apnea/hypopnea index, AHI ≥15) or mild sleep disordered breathing (AHI 5-15) with daytime sleepiness (Epworth Sleepiness Scale >10)
- •Moderate-to-severe insomnia (Insomnia Severity Index >14)
- •Restless leg syndrome (as per the Cambridge-Hopkins questionnaire)
- •Excessive daytime sleepiness (Epworth Sleepiness Scale >15)
- •Extreme chronotype (Morningness-Eveningness Questionnaire >69 or <31)
- •Night shift work
- •Ongoing participation in other research studies (as per the investigators' judgment)
- •Any other medical, geographic, or social factor making study participation impractical
- •Not English-speaking and/or inability to provide informed consent
- •Exclusionary for blood draws: hemoglobin <11.6 g/dL in women / <13.2 g/dL in men; participants with measured hemoglobin levels below these thresholds will be allowed to continue participate in study tests and procedures not involving blood draws.
研究组 & 干预措施
Study Sequence BA
Normal sleep condition in the first period and sleep restriction condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.
干预措施: Partial sleep deprivation (sleep restriction) (Behavioral)
Study Sequence BA
Normal sleep condition in the first period and sleep restriction condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.
干预措施: Normal sleep (Behavioral)
Study Sequence AB
Sleep restriction condition in the first period and normal sleep condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.
干预措施: Partial sleep deprivation (sleep restriction) (Behavioral)
Study Sequence AB
Sleep restriction condition in the first period and normal sleep condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.
干预措施: Normal sleep (Behavioral)
结局指标
主要结局
24-hour Systolic Blood Pressure (BP)
时间窗: Day 2, Day 4, Day 7, and Day 9
Systolic Blood pressure will be measured in mmHg
次要结局
- Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping(Day 2, Day 4, Day 7, and Day 9)
- 24-hour Diastolic blood pressure (DBP)(Day 2, Day 4, Day 7, and Day 9)
- Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)(Day 2, Day 4, Day 7, and Day 9)
- Baroreflex Sensitivity(Day 3, Day 5, Day 8, and Day 10)
- Catecholamines(Day 2, Day 4, Day 7, and Day 9)
- Blood Pressure (BP) response to stressors(Day 3, Day 5, Day 8, and Day 10)
- DNA-methylation(Day 3, Day 5, Day 8, and Day 10)
- Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)(Day 2, Day 4, Day 7, and Day 9)
- Endothelial Function(Day 3, Day 5, Day 8, and Day 10)
- Heart Rate response to stressors(Day 3, Day 5, Day 8, and Day 10)
- Transcriptomic(Day 3, Day 5, Day 8, and Day 10)
研究者
Naima Covassin
Principal Investigator
Mayo Clinic