Clinical trial NCT05918744: Sleep and Vascular Health Study
Official title: Sleep Extension and Vascular Health Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Vascular Diseases
Metabolic Disease
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure reactivity
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Passive Leg movement
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Circulating intercellular adhesion molecule 1 (ICAM-1)
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Circulating Vascular adhesion molecule 1 (VCAM-1)
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Objective sleep duration
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Objective sleep efficiency
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Subjective sleep duration
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Subjective sleep quality
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Subjective Sleepiness
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Pulse wave analysis
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Pulse wave velocity
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Cognitive motor task
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Circulating Leptin
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Circulating Ghrelin
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Pre- intervention
measure: Mental health - social anxiety
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Appetite Assessment
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Hematocrit
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Hemoglobin
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Urine Osmolarity
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Urine Electrolytes
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Blood Glucose
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Blood Cholesterol
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Circulating Insulin
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
measure: Oxidized LDL
timeFrame: Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
References:
citation: 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.
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.
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.
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.
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.