Blood PressureNDSVHNCT04576338
"Neighborhood Disadvantage, Sleep and Vascular Health"
An observational study of Blood Pressure and Sleep, run by Auburn University at 1 site in United States.
Trial summary
The purpose of the study is to find out the effects of neighborhood disadvantage and sleep disparities contribute to racial disparities in cardiometabolic health and blood pressure in young adults. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Sleep, Racism
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The cohort consists of Black and White college students at a university in a southeastern state in America. The cohort will be, by design, generally healthy, young adults free from known cardiometabolic disease,
Who may be able to join
- -
Who cannot join
- Systolic blood pressure greater than 150 mmHg
- Diastolic blood pressure greater than 90 mmHg
- Body mass index above 35 kg/m^2
- History of cardiovascular disease
- Recent (one year) history of cancer
- History of metabolic disease (e.g. type 2 diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Neighborhood Disadvantage, Sleep, and Vascular Health: Racial Disparities in Cardiometabolic Health and Blood Pressure"
The purpose of the study is to find out the effects of neighborhood disadvantage and sleep disparities contribute to racial disparities in cardiometabolic health and blood pressure in young adults.
Read the detailed description
There are well-documented disparities between Black and white Americans in the incidence of cardiovascular disease, the leading cause of death in America. There are also disparities between Black and White Americans in the incidence of hypertension (high blood pressure; BP), which is the leading risk factor for cardiovascular disease. Our long-term goal is to determine effective strategies to prevent racial disparities in cardiovascular health. In this proposal, the investigators will focus on determining societal and biological mediators of racial disparities in young adults that can be targeted in future interventions. Poor sleep is associated with adverse cardiovascular events and hypertension. Moreover, recent meta-analyses demonstrate that Black adults have consistently poorer sleep health than White adults, including receiving fewer total sleep minutes and having worse overall sleep quality. Neighborhood socioeconomic environments influence health behaviors through both material resources (e.g., access to healthful foods and safe public space) and social norms (e.g. exercise, diet, smoking). A well-documented history of discriminatory policies and practices has resulted in black individuals living in more disadvantaged physical and social environments than whites. As such, they experience greater adverse exposures (e.g., racism, violence and stress), which negatively impact sleep, resulting in dysregulation of cardiometabolic health. Therefore, the investigators seek to determine the role of neighborhood disadvantage and sleep in contributing to racial disparities in cardiovascular health.
- Conditions
- Blood Pressure, Sleep, Racism, Stiffness, Arterial, Endothelial Dysfunction
- Keywords
- blood pressure, sleep, endothelial dysfunction, social determinants of health, arterial stiffness
- Medical subject headings
- Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| College Students | The cohort consists of Black and White college students at a university in a southeastern state in America. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation (FMD)
Flow-mediated vasodilation will be assessed using continuous measures of brachial artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70). The brachial artery will be imaged in the longitudinal plane proximal to the medial epicondyle using a high-frequency (6-12 MHz) linear-array probe. The ultrasound probe will be stabilized using a custom-built clamp. Shear rate (sec-1) will be calculated as [(blood flow velocity (cm*s-1) *4)/blood vessel diameter (mm)] The image will be recorded throughout a 60-s baseline, a 300-s ischemic stimulus (250 mmHg), and 180 seconds post deflation. FMD will be expressed as % dilation (final diameter-baseline diameter/baseline diameter x 100) and also normalized to the shear stimulus. Allometric scaling will be used if appropriate, including if there are baseline differences in artery diameter by race or condition.
Measured: Baseline racial comparison
Pulse wave velocity (arterial stiffness)
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded.PWV will be expressed as cm/s.
Measured: Baseline racial comparison
Pulse wave analysis (arterial stiffness)
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) using an upper arm blood pressure cuff. PWA will be expressed as % (calculated as augmentation pressure divided by the pulse pressure).
Measured: Baseline racial comparison
24-hour ambulatory blood pressure
Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours preceding their study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.
Measured: Baseline racial comparison
Blood pressure reactivity
The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
Measured: Baseline racial comparison
Objective sleep duration and quality
Philips actiwatch spectrum will be used to quantify sleep duration. Participants will wear the watch units for 7 days. The investigators will cross-check actigraphy wear times with a sleep diary.
Measured: Baseline racial comparison
Subjective sleep quality
The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to asses sleep duration and perceived sleep quality reflective of the one month period leading into the study. The PSQI global score has a possible range of 0-21 points.
Measured: Baseline racial comparison
Secondary outcomes (7)
Circulating reactive oxygen species
The investigators will use electron paramagnetic resonance to measure reactive oxygen species (spectra units) in whole blood samples treated with a spin probe.
Measured: Baseline racial comparison
Blood biomarkers of nitric oxide bioavailability
The investigators will measure nitric oxide metabolites (nitrate and nitrite nanomolar concentration) using chemiluminescence
Measured: Baseline racial comparison
Physical activity
Participants will wear an ActiGraph GT3X accelerometer for seven days to objectively quantify steps per day and metabolic equivalents per day.
Measured: Baseline racial comparison
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.
Measured: Baseline racial comparison
Mental health - depression
The investigators will administer the Beck's Depression Inventory. The scale starts at 0 and ends at 3 for 21 questions related to depression.
Measured: Baseline racial comparison
Neighborhood disadvantage
The investigators will ask participants to identify their home addresses with investigator assistance and Google maps and potential assistance from their guardians or parents during early- and mid-childhood and adolescence. The investigators will use the participant's address and census tract information to determine measures of neighborhood quality such as median income, crime rates, and median education level.
Measured: Baseline racial comparison
Habitual dietary intake
The investigators will instruct participants to complete a diet log for 5 days which will be operationalized with Nutrition Data System for Research (NDSR).
Measured: Baseline racial comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start11 Jan 2020
- Primary completion1 Apr 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Austin Robinson, Auburn University
- Investigators
- Austin T Robinson, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576338
- Sponsor's protocol ID
- AU IRB #20-262 FB
- Acronym
- NDSVH
- Status last verified
- Aug 2024
- First submitted
- 19 Sep 2020
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
Publications
Jeong S, Linder BA, Barnett AM, Tharpe MA, Hutchison ZJ, Culver MN, Sanchez SO, Nichols OI, Grosicki GJ, Bunsawat K, Nasci VL, Gohar EY, Fuller-Rowell TE, Robinson AT. Interplay of race and neighborhood deprivation on resting and ambulatory blood pressure in young adults. Am J Physiol Heart Circ Physiol. 2024 Sep 1;327(3):H601-H613. doi: 10.1152/ajpheart.00726.2023. Epub 2024 Jul 12.
PubMed 38995211Robinson AT, Linder BA, Barnett AM, Jeong S, Sanchez SO, Nichols OI, McIntosh MC, Hutchison ZJ, Tharpe MA, Watso JC, Gutierrez OM, Fuller-Rowell TE. Cross-sectional analysis of racial differences in hydration and neighborhood deprivation in young adults. Am J Clin Nutr. 2023 Oct;118(4):822-833. doi: 10.1016/j.ajcnut.2023.08.005. Epub 2023 Aug 22.
PubMed 37619651Culver MN, Linder BA, Lyons DE, Hutchison ZJ, Garrett CL, McNeil JN, Robinson AT. Do not sleep on vitamin D: vitamin D is associated with sleep variability in apparently healthy adults. Am J Physiol Regul Integr Comp Physiol. 2025 Mar 1;328(3):R262-R273. doi: 10.1152/ajpregu.00168.2024. Epub 2025 Jan 28.
PubMed 39873709Jeong S, Linder BA, Barnett AM, Tharpe MA, Hutchison ZJ, Culver MN, Sanchez SO, Nichols OI, Grosicki GJ, Bunsawat K, Nasci VL, Gohar EY, Fuller-Rowell TE, Robinson AT. Interplay of Race and Neighborhood Deprivation on Ambulatory Blood Pressure in Young Adults. medRxiv [Preprint]. 2023 Sep 12:2023.09.11.23295160. doi: 10.1101/2023.09.11.23295160.
PubMed 37745604
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Neighborhood Disadvantage, Sleep, and Vascular Health: Racial Disparities in Cardiometabolic Health and Blood Pressure"
- ClinicalTrials.gov ID
- NCT04576338
- Acronym / sponsor ID
- NDSVH / AU IRB #20-262 FB
- Conditions
- Blood Pressure, Sleep, Racism, Stiffness, Arterial, Endothelial Dysfunction
- Keywords
- blood pressure, sleep, endothelial dysfunction, social determinants of health, arterial stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to find out the effects of neighborhood disadvantage and sleep disparities contribute to racial disparities in cardiometabolic health and blood pressure in young adults.
Detailed description
There are well-documented disparities between Black and white Americans in the incidence of cardiovascular disease, the leading cause of death in America. There are also disparities between Black and White Americans in the incidence of hypertension (high blood pressure; BP), which is the leading risk factor for cardiovascular disease. Our long-term goal is to determine effective strategies to prevent racial disparities in cardiovascular health. In this proposal, the investigators will focus on determining societal and biological mediators of racial disparities in young adults that can be targeted in future interventions. Poor sleep is associated with adverse cardiovascular events and hypertension. Moreover, recent meta-analyses demonstrate that Black adults have consistently poorer sleep health than White adults, including receiving fewer total sleep minutes and having worse overall sleep quality. Neighborhood socioeconomic environments influence health behaviors through both material resources (e.g., access to healthful foods and safe public space) and social norms (e.g. exercise, diet, smoking). A well-documented history of discriminatory policies and practices has resulted in black individuals living in more disadvantaged physical and social environments than whites. As such, they experience greater adverse exposures (e.g., racism, violence and stress), which negatively impact sleep, resulting in dysregulation of cardiometabolic health. Therefore, the investigators seek to determine the role of neighborhood disadvantage and sleep in contributing to racial disparities in cardiovascular health.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| College Students | – | –The cohort consists of Black and White college students at a university in a southeastern state in America. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The cohort consists of Black and White college students at a university in a southeastern state in America. The cohort will be, by design, generally healthy, young adults free from known cardiometabolic disease,
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- Systolic blood pressure greater than 150 mmHg
- Diastolic blood pressure greater than 90 mmHg
- Body mass index above 35 kg/m^2
- History of cardiovascular disease
- Recent (one year) history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flow-mediated dilation (FMD)
Time frame: Baseline racial comparison
Flow-mediated vasodilation will be assessed using continuous measures of brachial artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70). The brachial artery will be imaged in the longitudinal plane proximal to the medial epicondyle using a high-frequency (6-12 MHz) linear-array probe. The ultrasound probe will be stabilized using a custom-built clamp. Shear rate (sec-1) will be calculated as [(blood flow velocity (cm*s-1) *4)/blood vessel diameter (mm)] The image will be recorded throughout a 60-s baseline, a 300-s ischemic stimulus (250 mmHg), and 180 seconds post deflation. FMD will be expressed as % dilation (final diameter-baseline diameter/baseline diameter x 100) and also normalized to the shear stimulus. Allometric scaling will be used if appropriate, including if there are baseline differences in artery diameter by race or condition.
Pulse wave velocity (arterial stiffness)
Time frame: Baseline racial comparison
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded.PWV will be expressed as cm/s.
Pulse wave analysis (arterial stiffness)
Time frame: Baseline racial comparison
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) using an upper arm blood pressure cuff. PWA will be expressed as % (calculated as augmentation pressure divided by the pulse pressure).
24-hour ambulatory blood pressure
Time frame: Baseline racial comparison
Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours preceding their study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.
Blood pressure reactivity
Time frame: Baseline racial comparison
The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
Objective sleep duration and quality
Time frame: Baseline racial comparison
Philips actiwatch spectrum will be used to quantify sleep duration. Participants will wear the watch units for 7 days. The investigators will cross-check actigraphy wear times with a sleep diary.
Subjective sleep quality
Time frame: Baseline racial comparison
The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to asses sleep duration and perceived sleep quality reflective of the one month period leading into the study. The PSQI global score has a possible range of 0-21 points.
7 secondary outcomes
Circulating reactive oxygen species
Time frame: Baseline racial comparison
Blood biomarkers of nitric oxide bioavailability
Time frame: Baseline racial comparison
Physical activity
Time frame: Baseline racial comparison
Mental health - social anxiety
Time frame: Baseline racial comparison
Mental health - depression
Time frame: Baseline racial comparison
Neighborhood disadvantage
Time frame: Baseline racial comparison
Habitual dietary intake
Time frame: Baseline racial comparison
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Results publication: PubMed 38995211Jeong S, Linder BA, Barnett AM, Tharpe MA, Hutchison ZJ, Culver MN, Sanchez SO, Nichols OI, Grosicki GJ, Bunsawat K, Nasci VL, Gohar EY, Fuller-Rowell TE, Robinson AT. Interplay of race and neighborhood deprivation on resting and ambulatory blood pressure in young adults. Am J Physiol Heart Circ Physiol. 2024 Sep 1;327(3):H601-H613. doi: 10.1152/ajpheart.00726.2023. Epub 2024 Jul 12.
- Results publication: PubMed 37619651Robinson AT, Linder BA, Barnett AM, Jeong S, Sanchez SO, Nichols OI, McIntosh MC, Hutchison ZJ, Tharpe MA, Watso JC, Gutierrez OM, Fuller-Rowell TE. Cross-sectional analysis of racial differences in hydration and neighborhood deprivation in young adults. Am J Clin Nutr. 2023 Oct;118(4):822-833. doi: 10.1016/j.ajcnut.2023.08.005. Epub 2023 Aug 22.
- Derived from this study: PubMed 39873709Culver MN, Linder BA, Lyons DE, Hutchison ZJ, Garrett CL, McNeil JN, Robinson AT. Do not sleep on vitamin D: vitamin D is associated with sleep variability in apparently healthy adults. Am J Physiol Regul Integr Comp Physiol. 2025 Mar 1;328(3):R262-R273. doi: 10.1152/ajpregu.00168.2024. Epub 2025 Jan 28.
- Derived from this study: PubMed 37745604Jeong S, Linder BA, Barnett AM, Tharpe MA, Hutchison ZJ, Culver MN, Sanchez SO, Nichols OI, Grosicki GJ, Bunsawat K, Nasci VL, Gohar EY, Fuller-Rowell TE, Robinson AT. Interplay of Race and Neighborhood Deprivation on Ambulatory Blood Pressure in Young Adults. medRxiv [Preprint]. 2023 Sep 12:2023.09.11.23295160. doi: 10.1101/2023.09.11.23295160.
- Individual participant dataSharing planned: Yes. Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austin T Robinson, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Sleep, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation (FMD) (time frame: Baseline racial comparison). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04576338, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.