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Active, Not Recruiting

NCT Number: NCT05918744

Sleep and Vascular Health Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sleep Cardiovascular Diseases Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sleep Extension

Behavioral

Participants will extend their time in bed by one hour for 2 weeks while being monitored.

Primary outcomes

  1. Blood pressure reactivity

    Time frame: 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.

  2. Passive Leg movement

    Time frame: 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.

  3. Circulating intercellular adhesion molecule 1 (ICAM-1)

    Time frame: 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.

  4. Circulating Vascular adhesion molecule 1 (VCAM-1)

    Time frame: 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

  5. Objective sleep duration

    Time frame: 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.

  6. Objective sleep efficiency

    Time frame: 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.

  7. Subjective sleep duration

    Time frame: 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.

  8. Subjective sleep quality

    Time frame: 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.

  9. Subjective Sleepiness

    Time frame: 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).

  10. Pulse wave analysis

    Time frame: 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).

  11. Pulse wave velocity

    Time frame: 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.

  12. Cognitive motor task

    Time frame: 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.

  13. Circulating Leptin

    Time frame: 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.

  14. Circulating Ghrelin

    Time frame: 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.

Secondary outcomes

  1. Cardiorespiratory fitness

    Time frame: Pre- intervention

    The investigators will use indirect calorimetry to measure the participant's maximal oxygen consumption (VO2max) during incremental exercise on a treadmill. The investigators will use a Parvo TrueOne metabolic cart and Woodway treadmill.

  2. Mental health - social anxiety

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

    The investigators will administer the Liebowitz Social Anxiety Scale. The scale starts at 0 (none) and ends at 3 (severe) for 24 questions related to anxiety and avoidance, and a cumulative score is calculated.

  3. Appetite Assessment

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

    Appetite assessment via a visual analog scale (0 not feeling hungry/thirsty to 150 hungry/thirsty) and an ad libitum breakfast to measure food intake will take place during each of the experimental visits.

  4. Hematocrit

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

    Blood samples will be analyzed for hematocrit content (Thermo Hematocrit Microcentrifuge).

  5. Hemoglobin

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

    Blood samples will be analyzed for hemoglobin content (HemoCue, radiometer)

  6. Urine Osmolarity

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

    Researchers will analyze 24-hour urine samples for osmolarity (AI Osmometer 3D3)

  7. Urine Electrolytes

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

    Researchers will analyze 24-hour urine samples for electrolyte (Na, K, Cl) content using the SmartLyte Electrolyte Analyzer. The Na, K, Cl will be expressed as milliequivalents (mEq).

  8. Blood Glucose

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

    Researchers will analyze blood for glucose concentrations using the Cholestech.

  9. Blood Cholesterol

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

    Researchers will analyze blood for cholesterol (total, LDL and HDL) using the Cholestech.

  10. Circulating Insulin

    Time frame: 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.

  11. Oxidized LDL

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study title

Sleep Extension and Vascular Health Study

Acronym: SAVHS

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 26, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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