Sleep and Vascular Health Study

NCT ID: NCT05918744

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-05-05

Brief Summary

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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

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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).

Conditions

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Sleep Vascular Diseases Metabolic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Habitual Sleep

Participants will follow their normal sleep schedule for 2 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Sleep extension

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

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type BEHAVIORAL

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

Interventions

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Sleep Extension

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Auburn University

OTHER

Sponsor Role lead

Responsible Party

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Austin Robinson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Auburn University

Auburn, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19932976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31753739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29073412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35766027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34010956 (View on PubMed)

Other Identifiers

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AU IRB #23-172

Identifier Type: -

Identifier Source: org_study_id

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