ClinicalTrials.gg
RecruitingNCT06029348CHARMUpdated Sep 16, 2026

Cerebrovascular Health and Resilience in Midlife

An interventional study of Paced Auditory Serial Addition Task in Psychological Stress, Cardiovascular Diseases and Cerebrovascular Disorders, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 40 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Not applicable
Ages
40 Years to 59 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 290 studies in Stress, Psychological with a site in United States — 31 open to participants now, 47 under way, 1 of them phase 3. Stress, Psychological · United States.

Planned enrollment
23rd of 262
450 · median 84
Started
2023
with 28 others
No phase
240 of 290
25 open now
Primary completion
2029-06
later than 43 of 46 live
Registered
236th of 290
by date
Lead sponsor
5 of 290
University of Pittsburgh

Among the 290 studies in Stress, Psychological with a site in United States, this one is the 23rd largest by planned enrollment of the 262 interventional ones that give a count, is one of 29 that started in 2023, is one of 240 with no phase, reaches primary completion later than 43 of the 46 other live ones, and was the 236th registered.

Stress, Psychological

848 studies on the registry are indexed under Stress, Psychological; 139 are open to participants now.

Browse Stress, Psychological studies →

Open to participants now

31 of the 290 studies in Stress, Psychological with a site in United States are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 75 Stress, Psychological studies recruiting now, 34 (45%) set no upper age limit and 37 (49%) stop at 75 or younger; 14 take children under 18; 49 take healthy volunteers.

This study: 40 Years to 59 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 290 studies in Stress, Psychological with a site in United States, or all of them as a file.
02

Study summary

This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview. In that session, volunteers would then be asked to undergo evaluations of their body composition, blood pressure, heart rate, and other signs of cardiovascular function and health. Lastly, volunteers would be asked to take part in a brief and challenging psychological task after a period of rest while cardiovascular activity is measured. In the other session, volunteers are asked to undergo magnetic resonance imaging and to complete neuropsychological tests of memory, attention, and processing speed. In addition to these two sessions, volunteers are asked to complete online questionnaires. The study is designed to examine associations between transient changes in cardiovascular activity induced by the psychological task, measures of overall cardiovascular health, and measures of cerebrovascular health measured by magnetic resonance imaging. Study results are expected to provide new information about the relationships between cardiovascular activity changes to psychological challenges and cardiovascular and cerebrovascular health in adults.

Read the detailed description

This cross-sectional study examines the extent to which cardiovascular responses to the acute experience of psychological stress relate to signs of cerebrovascular health detected on magnetic resonance imaging. Study volunteers will include midlife adults who do not report having a history of clinical cardiovascular disease or dementia. Study volunteers will be asked to complete protocols to assess: behavioral, social, and biological correlates of cardiovascular and cerebrovascular health; arterial stiffness, endothelial function, and beat-to-beat blood pressure; cardiovascular changes to acute psychological stress; signs of cerebrovascular health; and, neuropsychological test performance. Cardiovascular responses to acute psychological stress will be examined in relation to indicators of brain function and structure, as well as indicators of cardiac and vascular function. Study results may help to increase knowledge about stress-related factors and cardiovascular sources of brain health.

03

Conditions studied

  • Psychological Stress
  • Cardiovascular Diseases
  • Cerebrovascular Disorders
04

Who can participate

Ages eligible
40 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able to attend 2 study visits at the University of Pittsburgh campus in Oakland (Pennsylvania)
  • Able to read and speak English

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >100 mmHg)
  • Current use of anticonvulsant, anti-Parkinson, neuroleptic, or antipsychotic medications
  • Current use of (e.g., oral prednisone) or ephedrine
  • Current chronic conditions of the lungs, liver and kidney, as well as cancer (chemotherapy and radiation) treatment in the past 12 months (allowances are made for non-melanoma skin cancer treatment, controlled asthma, and allergy inhalers)
  • Self-reported major neurological disorders or brain injuries (e.g., multiple sclerosis, cerebral palsy, major head injury)
  • Self-reported psychotic illnesses (mania, bipolar disorder, schizophrenia)
  • Current pregnancy or childbirth within the past 6 months
  • Suspected mild cognitive impairment or dementia
  • Self reported sleep apnea
  • Self-reported history of myocardial infarction, stroke, or revascularization procedures, as well as treatment for cardiac arrhythmias
  • Self-reported lack of comfort to undergo MRI testing
  • Presence of implants or objects that are unsafe for MRI (e.g., tattooed eyeliner), as well as any other that would prevent MRI testing
  • Self-reported lack of comfort to undergo the laboratory math task
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    Paced Auditory Serial Addition Task

    For the Paced Auditory Serial Addition Task, volunteers are presented with single digit numbers (1-9), and are instructed to add any given number to the previously presented number, and call out the answer. Volunteers are told that their performance is being monitored by research assistants. Volunteers are provided with a signaling device that they can use to discontinue testing. Lastly, participants will be asked to complete brief questionnaires to assess their levels of experienced threat, challenge, valence, arousal, and sense of control.

    Behavioral: Paced Auditory Serial Addition Task

Interventions

  • BehavioralPaced Auditory Serial Addition Task

    Study volunteers will be asked to complete a 4-minute Paced Auditory Serial Addition Task, which is a standardized task that is widely used to study cardiovascular responses to acute psychological challenges (or stressors) in a laboratory setting.

06

What researchers measure

Primary outcomes

  1. Change in systolic blood pressure (SBP) from baseline to task

    The mean SBP from the baseline period will be subtracted from the mean of the task period.

    Time frame: Mean SBPs for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period

  2. White matter hyperintensity burden

    White matter hyperintensity burden will be computed as the total sum of the voxels segmented as hyperintensities multiplied by voxel dimensions to yield a total score (units of mm-cubed).

    Time frame: Derived from one acquisition sequence within in a 50 min multimodal MRI protocol

  3. Hippocampal volume

    Total bilateral hippocampal volume will be computed as the total sum of voxels automatically segmented.

    Time frame: Derived from one acquisition sequence within a 50 min multimodal MRI protocol

  4. Perivascular space volume

    Total perivascular space volume will be computed from segmented brain blood vessel-tissue interfaces.

    Time frame: Derived from one acquisition sequence in a 50 min multimodal MRI protocol

  5. Pulse wave velocity

    Pulse wave velocity in m/s will be assessed by dual impedance cardiography as a non-invasive indicator of arterial stiffness. This measure will be derived from the 5 minute baseline period.

    Time frame: 5 minutes

  6. Spontaneous baroreflex sensitivity

    Spontaneous baroreflex sensitivity in ms/mmHg will be computed by the sequence method applied to beat-to-beat blood pressure and electrocardiogram recordings.

    Time frame: 5 minutes

  7. Endothelial function

    Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring.

    Time frame: 15 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data that comprise primary and secondary study outcomes will be made available with data dictionaries via the University of Pittsburgh's repository, D-Scholarship@Pitt. This repository provides indefinite storage and accessibility. Along with de-identified data, other shared resources will include a description of data collection methods and study code book; a description of the data files; and descriptions of data use conditions. Statistical scripts will be deposited as appropriate following publication of manuscripts bearing on the aims of the study. All publications will include information on the location of study data and accessibility. Requests by researchers for other de-identified data will be facilitated by completion of a Data Use Agreement, as well as provision of a methodologically sound proposal and approval from their institution.

Supporting information: Study protocol

Time frame: Data are anticipated to become available within 12 months after the publication of findings bearing on the Specific Aims of R01HL169990

Access criteria: All presentations and publications will include information on the location of study data and its public accessibility for research use. The criteria for certain requests of de-identified data will involve the completion of a Data Use Agreement, https://www.osp.pitt.edu/osp-teams/clinical-corporate-contract-services/negotiations/data-use-agreements-duas

Data sharing details ↗ · d-scholarship.pitt.edu

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Jun 2029, 68 months after the start.

Of 459 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 68 months is above that.

Counting every sponsor, half of 472 studies reached it within 13 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2023
First posted
Sep 8, 2023
StartActual
Oct 17, 2023
Primary completionEst.
Jun 30, 2029
CompletionEst.
Jun 30, 2029
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06029348
Responsible party
Peter Gianaros (Professor, University of Pittsburgh) — Principal investigator
First posted
Sep 8, 2023
Start date
Oct 17, 2023
Primary completion
Jun 30, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Sep 16, 2026

Study contacts

Peter J Gianaros, PhD
Contact
bnl@pitt.edu
412-624-4500
Sara Boyko, BS
Contact
bnl@pitt.edu
412-648-9047
Peter J Gianaros, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion