Sleep and Circadian Mechanisms Contributing to Nocturnal Non-dipping Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
This study will be the first to distinguish the relative contributions of sleep, circadian and behavioral mechanisms to the non-dipping BP profile in Black adults and will lay the groundwork for optimizing therapies dependent on mechanisms, such as targeting sleep, targeting circadian rhythmicity, or targeting behaviors, and raising the possibility that ideal therapy for hypertension (HTN) may differ by race. This research will ultimately help to improve health and survival in black populations with HTN.
详细描述
By studying standardized behaviors and regulators of BP during sleep and behavioral stresses across all circadian phases, this protocol will allow us specifically to:
- To determine if poor sleep, while controlling for circadian phase, contributes to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.
- To determine if reduced BP responses to standardized behavioral changes across the day and night contribute to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.
- To determine if reduced circadian amplitude of BP contributes to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identified Black or White
- •'normotensive' (resting systolic blood pressure (SBP) <140/90 mmHg) or uncomplicated stage 1 'hypertensive' (systolic BP between 140 and 160 mmHg or a diastolic (DBP) between 90 and 100 mmHg).
- •free of all prescription and non-prescription drugs (including caffeine, nicotine, alcohol and herbal medications)
排除标准
- •Currently treated with pharmacologic agents for hypertension
- •Blood pressure >160/100 mmHg
- •Smoked within the last year
- •Regular night work or rotating shift work for the three months prior to the study
- •Travel across more than three time zones during the three months prior to the study.
- •Any acute, chronic or debilitating medical conditions, other than mild hypertension (140<SBP<160 or 90<DBP<100 mmHg) and severe renal disease (glomerular filtration rate <30)
- •Moderate to severe obstructive sleep apnea (OSA)
- •History of severe psychiatric illnesses or psychiatric disorders will be excluded, including alcoholism, drug dependency, major depression, manic depressive illness, schizophrenic disorders, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder.
研究组 & 干预措施
White Adults
White adults aged 30-60 with a BMI of 18.5<BMI<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
干预措施: Forced Desynchrony (Behavioral)
Black Adults
Black adults aged 30-60 with a BMI of 18.5<BMI<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
干预措施: Forced Desynchrony (Behavioral)
结局指标
主要结局
Blood pressure
时间窗: 7-day lab stay
Blood pressure will be measured via automatic and manual-operated sphygmomanometer. Readings will be recorded in units of mmHg.
Heart rate variability
时间窗: 7-day lab stay
Two channel ECG will be recorded for heart rate variability analysis.
Nighttime Systolic Blood Pressure
时间窗: Baseline Night Average
Systolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg.
Nighttime Diastolic Blood Pressure
时间窗: Baseline Night Average
Diastolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg.
Daytime Systolic Blood Pressure
时间窗: Baseline Daytime Average
Systolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg.
Daytime Diastolic Blood Pressure
时间窗: Baseline Daytime Average
Diastolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg.
Change in Systolic Blood Pressure Across Sleep Period
时间窗: 7 days in the laboratory
Change in systolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out).
Change in Diastolic Blood Pressure Across Sleep Period
时间窗: 7 days in the laboratory
Change in diastolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out).
Circadian Amplitude of Systolic Blood Pressure When Awake
时间窗: 7 days in the laboratory
Systolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of systolic blood pressure while controlling for (averaging out) any ongoing behaviors.
Circadian Amplitude of Diastolic Blood Pressure When Awake
时间窗: 7 days in the laboratory
Diastolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of diastolic blood pressure while controlling for (averaging out) any ongoing behaviors.
次要结局
- saliva cortisol(7-day lab stay)
- venous norepinephrine(7-day lab stay)
- venous aldosterone(7-day lab stay)
- venous endocannabinoids(7-day lab stay)
- venous epinephrine(7-day lab stay)
- saliva melatonin(7-day lab stay)
- beat-by-beat blood pressure(7-day lab stay)
- 24-hr ambulatory blood pressure(2 day ambulatory period)
- flow mediated dilation(7-day lab stay)
研究者
Steven A. Shea
Director
Oregon Health and Science University