Sleep and Vascular Health Study (SAVHS)
Primary Purpose
Sleep, Vascular Diseases, Metabolic Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Extension
Sponsored by
About this trial
This is an interventional prevention trial for Sleep
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
Sites / Locations
- Auburn UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Habitual Sleep
Sleep extension
Arm Description
Participants will follow their normal sleep schedule for 2 weeks.
Participants will extend their time in bed by one hour for 2 weeks while being monitored.
Outcomes
Primary Outcome Measures
Blood pressure reactivity
The investigators will measure blood pressure using photoplethysmography at the finger during rest and handgrip exercise.
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.
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.
Circulating Vascular adhesion molecule 1 (VCAM-1)
VCAM-1 will be assessed using ELISA ; samples will be run in triplicate and with quality controls
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.
Objective sleep efficiency
Philips actiwatch spectrum will be used to quantify % of time in bed actually spent sleeping to calculate sleep efficiency.
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.
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.
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).
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).
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.
Cognitive motor task
The investigators will use a dual task assessment that involves walking an responding to prompts.
Circulating Leptin
Blood sample will be analyses with an enzyme-linked immunosorbent assay (ELISA) kit.
Circulating Ghrelin
Blood sample will be analysed with an enzyme-linked immunosorbent assay (ELISA) kit.
Secondary Outcome Measures
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.
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.
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.
Hematocrit
Blood samples will be analyzed for hematocrit content (Thermo Hematocrit Microcentrifuge).
Hemoglobin
Blood samples will be analyzed for hemoglobin content (HemoCue, radiometer)
Urine Osmolarity
Researchers will analyze 24-hour urine samples for osmolarity (AI Osmometer 3D3)
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).
Blood Glucose
Researchers will analyze blood for glucose concentrations using the Cholestech.
Blood Cholesterol
Researchers will analyze blood for cholesterol (total, LDL and HDL) using the Cholestech.
Circulating Insulin
Blood sample will be analyses with an enzyme-linked immunosorbent assay (ELISA) kit.
Oxidized LDL
Blood sample will be analyses with an enzyme-linked immunosorbent assay (ELISA) kit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05918744
Brief Title
Sleep and Vascular Health Study
Acronym
SAVHS
Official Title
Sleep Extension and Vascular Health Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
May 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Vascular Diseases, Metabolic Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Habitual Sleep
Arm Type
No Intervention
Arm Description
Participants will follow their normal sleep schedule for 2 weeks.
Arm Title
Sleep extension
Arm Type
Experimental
Arm Description
Participants will extend their time in bed by one hour for 2 weeks while being monitored.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Extension
Intervention Description
Participants will extend their time in bed by one hour for 2 weeks while being monitored.
Primary Outcome Measure Information:
Title
Blood pressure reactivity
Description
The investigators will measure blood pressure using photoplethysmography at the finger during rest and handgrip exercise.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Passive Leg movement
Description
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.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Circulating intercellular adhesion molecule 1 (ICAM-1)
Description
Researchers will assess circulating markers intercellular adhesion molecule 1 (ICAM-1) using ELISA; samples will be run in triplicate and with quality controls.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Circulating Vascular adhesion molecule 1 (VCAM-1)
Description
VCAM-1 will be assessed using ELISA ; samples will be run in triplicate and with quality controls
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Objective sleep duration
Description
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.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Objective sleep efficiency
Description
Philips actiwatch spectrum will be used to quantify % of time in bed actually spent sleeping to calculate sleep efficiency.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Subjective sleep duration
Description
The investigators will use the Pittsburgh Sleep Quality Index to asses sleep duration reflective of the one month period leading into the study.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Subjective sleep quality
Description
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.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Subjective Sleepiness
Description
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).
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Pulse wave analysis
Description
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).
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Pulse wave velocity
Description
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.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Cognitive motor task
Description
The investigators will use a dual task assessment that involves walking an responding to prompts.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Circulating Leptin
Description
Blood sample will be analyses with an enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Circulating Ghrelin
Description
Blood sample will be analysed with an enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Secondary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
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.
Time Frame
Pre- intervention
Title
Mental health - social anxiety
Description
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.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Appetite Assessment
Description
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.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Hematocrit
Description
Blood samples will be analyzed for hematocrit content (Thermo Hematocrit Microcentrifuge).
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Hemoglobin
Description
Blood samples will be analyzed for hemoglobin content (HemoCue, radiometer)
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Urine Osmolarity
Description
Researchers will analyze 24-hour urine samples for osmolarity (AI Osmometer 3D3)
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Urine Electrolytes
Description
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).
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Blood Glucose
Description
Researchers will analyze blood for glucose concentrations using the Cholestech.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Blood Cholesterol
Description
Researchers will analyze blood for cholesterol (total, LDL and HDL) using the Cholestech.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Circulating Insulin
Description
Blood sample will be analyses with an enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
Title
Oxidized LDL
Description
Blood sample will be analyses with an enzyme-linked immunosorbent assay (ELISA) kit.
Time Frame
Change score from habitual sleep to day 15 (after 14 days of sleep extension)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin T Robinson, PhD
Phone
574-514-1034
Email
atr0026@auburn.edu
First Name & Middle Initial & Last Name & Degree
Meral N Culver, MS
Phone
3017428813
Email
mnc0049@auburn.edu
First Name & Middle Initial & Last Name & Degree
Austin T Robinson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19932976
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.
Results Reference
background
PubMed Identifier
31753739
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.
Results Reference
background
PubMed Identifier
29073412
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.
Results Reference
background
PubMed Identifier
35766027
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.
Results Reference
background
PubMed Identifier
34010956
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.
Results Reference
background
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Sleep and Vascular Health Study
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