Understanding how stress, sleep, and hormones affect heart health in midlife women
Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
This study is trying to see how stress, sleep, and hormone levels affect heart health in midlife women to find ways to reduce their risk of heart disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT06745466 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between estradiol levels, daily stress responses, and sleep variability on vascular function in midlife premenopausal women. It will assess how these factors contribute to cardiovascular disease risk, particularly focusing on the impact of estradiol suppression. Participants will undergo evaluations of their emotional responses to stress and sleep patterns over a period of time, with the goal of identifying potential interventions to improve vascular health. The study will utilize ganirelix acetate as part of its methodology.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women aged 40-55.
Not a fit: Patients who are pregnant, post-menopausal, or have significant chronic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing cardiovascular health in midlife women.
How similar studies have performed: While there is ongoing research in this area, the specific focus on the interplay of stress, sleep, and estradiol in midlife women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age 40-55 * Premenopausal Exclusion Criteria: * Pregnancy (including a positive urine pregnancy test), planning to become pregnant, or breast-feeding * Peri- or post-menopausal * Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease * Current or lifetime major psychiatric illness (e.g., major depressive disorder, bipolar disorder, schizophrenia, eating disorders) * History of hysterectomy (complete or partial), polycystic ovary syndrome, endometrial hyperplasia, irregular menstrual cycles, or endometrial ablation * Suspected potential presence of obstructive sleep apnea (STOP-Bang score \>3) or insomnia (Insomnia Severity Index score \>15) * Current or recent (within 8 wks) use of medications that could conceivably alter cardiovascular function or sleep health * Changes or alterations in medication status (starting a new, additional, or different medication or changing the dose of a current medication) * Body mass index \>35 kg/m2 * Tobacco or nicotine use, including vaping and electronic cigarettes * Working night-time or rotating shift work within the previous 3 months * Trans-meridian travel during study enrollment (inclusive of the entire duration of enrollment and the period between testing cycles) * Known allergies to pharmacological agents/drugs * Current use of long-acting reversible contraception (LARC; e.g., IUDs, birth control implants) * Known latex allergy
Where this trial is running
Newark, Delaware
- University of Delaware — Newark, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Jody Greaney, PhD — University of Delaware
- Study coordinator: Jody Greaney, PhD
- Email: jgreaney@udel.edu
- Phone: 302-831-3181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.