CompletedNot Applicable

Daily Stress and Vascular Function in Midlife as a Risk Factor for Cognitive Decline

United States17 participantsStarted 2024-05-30

Plain-language summary

The goal of this pilot clinical trial is to begin to understand how day-to-day stress affects cardiovascular health and brain function in middle-aged adults. The main question aims to answer is whether the link between daily stress and vascular dysfunction is a potential mechanism of increased risk for future cognitive decline. Participants will complete a 15-day testing cycle. During this cycle, participants will complete daily assessments of stress using an online survey tool for 14-consecutive days. On the last day of each cycle, vascular function will be assessed during a laboratory visit.

Who can participate

Age range

40 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females aged 40-55 yrs * Absence of objective cognitive impairment (≥26 on the Montreal Cognitive Assessment) * Absence of diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases, as determined by medical history, physical examination, blood chemistries, and 12-lead resting electrocardiogram * Participants must have a level of understanding of the English language sufficient to provide informed consent and to agree to all tests and procedures, as well as the capacity and willingness to attend all study related visits and to comply with the study protocol Exclusion Criteria: Subjects will be excluded at the discretion of the PI/collaborating clinicians or for any of the following reasons: * \<40 or \>55 yrs * Psychiatric illness aside from MDD (e.g., bipolar disorder, schizophrenia, eating disorders), assessed by the MINI and self-report * Objective cognitive impairment (\<26 on the Montreal Cognitive Assessment) * Diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases * Current or recent use (within 8 wks) of medications that alter cardiovascular function or psychoactive/psychopharmacological drugs * Body mass index ≥35 kg/m2 * Resting systolic BP ≥140 mmHg * HbA1c ≥5.7% * Direct low-density lipoprotein ≥160mg/dl * Tobacco use (including electronic cigarettes) * Females who are pregnant, brea…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nitric Oxide (NO)-Mediated Endothelium-dependent Dilation (EDD)

Timeframe: Day 15 following a standard local heating protocol, an average of 4 hours during the 15-day cycle

Trial details

NCT IDNCT06466655

SponsorUniversity of Delaware

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-10

Results submitted2025-07-11

View on ClinicalTrials.gov More Middle-aged Adults trials