Sleep and Vascular Health Study

NCT05918744 | Active Not Recruiting

• 1 other identifier: AU IRB #23-172
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Vascular Diseases; Metabolic Disease

Outcome Measures

Primary Outcomes (14)

• Blood pressure reactivity

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

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

• Passive Leg movement

  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.

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

• Circulating intercellular adhesion molecule 1 (ICAM-1)

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

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

• Circulating Vascular adhesion molecule 1 (VCAM-1)

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

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

• Objective sleep duration

  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.

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

• Objective sleep efficiency

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

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

• Subjective sleep duration

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

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

• Subjective sleep quality

  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.

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

• Subjective Sleepiness

  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).

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

• Pulse wave analysis

  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).

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

• Pulse wave velocity

  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.

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

• Cognitive motor task

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

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

• Circulating Leptin

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

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

• Circulating Ghrelin

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

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

Secondary Outcomes (11)

• 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)

• Hemoglobin

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

Study Arms (2)

Habitual Sleep

NO INTERVENTION

Participants will follow their normal sleep schedule for 2 weeks.

Sleep extension

EXPERIMENTAL

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

Behavioral: Sleep Extension

Interventions

Sleep Extension BEHAVIORAL

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

Sleep extension

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related Publications (5)

• Grandner MA, Hale L, Moore M, Patel NP. Mortality associated with short sleep duration: The evidence, the possible mechanisms, and the future. Sleep Med Rev. 2010 Jun;14(3):191-203. doi: 10.1016/j.smrv.2009.07.006. Epub 2009 Nov 25.

  PMID: 19932976 BACKGROUND

• Stock AA, Lee S, Nahmod NG, Chang AM. Effects of sleep extension on sleep duration, sleepiness, and blood pressure in college students. Sleep Health. 2020 Feb;6(1):32-39. doi: 10.1016/j.sleh.2019.10.003. Epub 2019 Nov 19.

  PMID: 31753739 BACKGROUND

• Hirshkowitz M, Whiton K, Albert SM, Alessi C, Bruni O, DonCarlos L, Hazen N, Herman J, Katz ES, Kheirandish-Gozal L, Neubauer DN, O'Donnell AE, Ohayon M, Peever J, Rawding R, Sachdeva RC, Setters B, Vitiello MV, Ware JC, Adams Hillard PJ. National Sleep Foundation's sleep time duration recommendations: methodology and results summary. Sleep Health. 2015 Mar;1(1):40-43. doi: 10.1016/j.sleh.2014.12.010. Epub 2015 Jan 8.

  PMID: 29073412 BACKGROUND

• Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.

  PMID: 35766027 BACKGROUND

• Krefman AE, Labarthe D, Greenland P, Pool L, Aguayo L, Juonala M, Kahonen M, Lehtimaki T, Day RS, Bazzano L, Muggeo VMR, Van Horn L, Liu L, Webber LS, Pahkala K, Laitinen TT, Raitakari O, Lloyd-Jones DM, Allen NB. Influential Periods in Longitudinal Clinical Cardiovascular Health Scores. Am J Epidemiol. 2021 Nov 2;190(11):2384-2394. doi: 10.1093/aje/kwab149.

  PMID: 34010956 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases; Metabolic Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will serve as their own controls. Due to the nature of the intervention (extending time in bed by 1 hour) all participants will be measured in their habitual sleep state followed by their extended sleep state.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 26, 2023
• Study Start: August 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: May 5, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)