Sleep and Vascular Health Study

Sleep Clinical Trial

— SAVHS  

Official title:

Sleep Extension and Vascular Health Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918744
• Other study ID #: AU IRB #23-172
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 5, 2025

Study information

• Verified date: June 2023
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 5, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Sleep
• Vascular Diseases

Intervention

Behavioral:
• Sleep Extension
Participants will extend their time in bed by one hour for 2 weeks while being monitored.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Cardiorespiratory fitness	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.	Pre- intervention
Secondary	Mental health - social anxiety	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.	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Appetite Assessment	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.	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Hematocrit	Blood samples will be analyzed for hematocrit content (Thermo Hematocrit Microcentrifuge).	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Hemoglobin	Blood samples will be analyzed for hemoglobin content (HemoCue, radiometer)	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Urine Osmolarity	Researchers will analyze 24-hour urine samples for osmolarity (AI Osmometer 3D3)	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Urine Electrolytes	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).	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Blood Glucose	Researchers will analyze blood for glucose concentrations using the Cholestech.	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Blood Cholesterol	Researchers will analyze blood for cholesterol (total, LDL and HDL) using the Cholestech.	Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary	Circulating Insulin	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)
Secondary	Oxidized LDL	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)