Recruiting

Cardiovascular Responses

Sponsor:

University of Pittsburgh

Code:

NCT06029348

Conditions

Psychological Stress

Cardiovascular Diseases

Cerebrovascular Disorders

Eligibility Criteria

Sex: All

Age: 40 - 59

Healthy Volunteers: Accepted

Interventions

Paced Auditory Serial Addition Task

Study Details

Brief 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.

Conditions

Psychological Stress

Cardiovascular Diseases

Cerebrovascular Disorders

Study ID

NCT06029348

Start date

Oct 17, 2023

Status verified date

Sep, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 59

Healthy Volunteers: Accepted

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:

  • 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 glucocorticoids (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 contraindications that would prevent MRI testing
  • Self-reported lack of comfort to undergo the laboratory math task

Study Design

Enrollment

450 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Paced 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.

Primary outcome measure

  • Change in systolic blood pressure (SBP) from baseline to task [ 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 ]
  • White matter hyperintensity burden [ Time Frame: Derived from one acquisition sequence within in a 50 min multimodal MRI protocol ]
  • Hippocampal volume [ Time Frame: Derived from one acquisition sequence within a 50 min multimodal MRI protocol ]
  • Perivascular space volume [ Time Frame: Derived from one acquisition sequence in a 50 min multimodal MRI protocol ]
  • Pulse wave velocity [ Time Frame: 5 minutes ]
  • Spontaneous baroreflex sensitivity [ Time Frame: 5 minutes ]
  • Endothelial function [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Peter J Gianaros, PhD

412-624-4500bnl@pitt.edu

Sara Boyko, BS

412-648-9047bnl@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

University of Pittsburgh

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-09-26.