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临床试验/NCT05918744
NCT05918744进行中(未招募)不适用

Sleep Extension and Vascular Health Study

Auburn University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Cognitive motor task

研究概览

简要总结

Habitual short sleep duration (< 7 hours/night) increases the risk of cardiovascular disease (CVD) and all-cause mortality. Yet most adults, especially emerging adults (i.e., 18-25 years) do not achieve the National Sleep Foundation recommendation of 7-9 hours of sleep each night. Additionally, the American Heart Association recently included sleep duration in the "Life's Essential 8". This recent development emphasizes the importance of sleep and the need to advance our understanding of how sleep impacts cardiometabolic health (CMH), particularly in emerging adults, a population whose CVD risk trajectory is malleable. Specifically, emerging adulthood is a critical age window when age-related loss of CMH accelerates. Based on my previous work and others, both self-reported and objective measures of poor sleep (e.g., duration, variability) are linked to early signs of elevated CVD risk in emerging adults, such as microvascular dysfunction and elevated central blood pressure (BP), which precede the development of hypertension.

详细描述

The investigators aim to address the knowledge gap on whether sleep extension is a viable strategy to improve CMH in emerging adults with habitual short sleep duration. A prior study demonstrated the feasibility of sleep extension to improve BP and perceived sleepiness in predominantly normotensive emerging adults (18-23 years). Even without hypertension, reductions in BP are generally beneficial for CMH. The research hypothesis is that sleep extension (one extra hour in bed per night) will improve CMH and health behaviors in emerging adults who self-report < 7 hours of sleep per night. The primary aim is to determine if sleep extension is effective in improving BP. Investigators will assess CMH after habitual sleep (2 weeks) followed by a 2-week sleep extension intervention in 60 emerging adults (~30 female).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 25 years old
  • self-report sleeping less than 7 hours a night on average
  • free from metabolic disease
  • free from liver disease
  • free from pulmonary disease
  • free from cardiovascular disease

排除标准

  • blood pressure higher than 140/80 mmHg
  • BMI greater than 35 kg/m2
  • use of blood thinners
  • history of sleeping disorders
  • no severe food allergies or eating disorders

结局指标

主要结局

Cognitive motor task

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

The investigators will use a dual task assessment that involves walking an responding to prompts.

Blood pressure reactivity

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

The investigators will measure blood pressure using photoplethysmography at the finger during rest and handgrip exercise.

Circulating Vascular adhesion molecule 1 (VCAM-1)

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

VCAM-1 will be assessed using ELISA ; samples will be run in triplicate and with quality controls

Objective sleep duration

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

Philips actiwatch spectrum will be used to quantify sleep duration. Participants will wear the watch units for 14 days. The investigators will assess sleep duration and cross-check actigraphy wear times with a sleep diary.

Subjective sleep duration

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

The investigators will use the Pittsburgh Sleep Quality Index to asses sleep duration reflective of the one month period leading into the study.

Pulse wave analysis

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) The sampling site is the brachial artery (upper alarm instrumented with a cuff for oscillometric sphygmomanometer). PWA will be expressed as % (calculated as augmentation pressure divided by the pulse pressure).

Pulse wave velocity

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV) The sampling site is the carotid artery (tonometry) and femoral artery (upper leg instrumented with a cuff for oscillometric sphygmomanometer). PWW will be expressed as meters per second.

Passive Leg movement

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

Passive leg movement will be used assessed blood flow responses to movement. The investigators will usie continuous measures of femoral artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70) to calculate blood flow at rest and with the passive lelg movement. The femoral artery will be imaged in the longitudinal plane distal to the inguinal crease using a high-frequency (10-12 MHz) linear-array probe. Participants will be in a seated, reclined position with the lower leg free hanging. The ultrasound probe will be positioned by a lab member and the image will be recorded throughout triplicate 60-s measurements. Another lab member will independently move the lower leg through 90º range of motion at a rate of 1 Hz.

Circulating intercellular adhesion molecule 1 (ICAM-1)

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

Researchers will assess circulating markers intercellular adhesion molecule 1 (ICAM-1) using ELISA; samples will be run in triplicate and with quality controls.

Subjective sleep quality

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

The investigators will use the Pittsburgh Sleep Quality Index to assess perceived sleep quality reflective of the one month period leading into the study. The global score scale is 0 to 21.

Subjective Sleepiness

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

The investigators will administer the Epworth Sleepiness Scale (ESS). The scale is scored as 0-10 (normal sleepiness), 11- 14 (mild sleepiness), 15-17 (moderate sleepiness), and 18 -24 (severe sleepiness).

Objective sleep efficiency

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

Philips actiwatch spectrum will be used to quantify % of time in bed actually spent sleeping to calculate sleep efficiency.

Circulating Leptin

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

Blood sample will be analyses with an enzyme-linked immunosorbent assay (ELISA) kit.

Circulating Ghrelin

时间窗: Change score from habitual sleep to day 15 (after 14 days of sleep extension)

Blood sample will be analysed with an enzyme-linked immunosorbent assay (ELISA) kit.

次要结局

  • Hemoglobin(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Blood Glucose(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Blood Cholesterol(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Cardiorespiratory fitness(Pre- intervention)
  • Mental health - social anxiety(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Appetite Assessment(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Hematocrit(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Urine Osmolarity(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Urine Electrolytes(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Circulating Insulin(Change score from habitual sleep to day 15 (after 14 days of sleep extension))
  • Oxidized LDL(Change score from habitual sleep to day 15 (after 14 days of sleep extension))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Austin Robinson

Assistant Professor

Auburn University

研究点 (2)

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