RECRUITING

Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women

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Conditions

EstrogenPremenopauseStressSleepVascular function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to identify the impact of estradiol (E2) on the associations between (a) responsivity to daily stress or (b) sleep variability with vascular function in midlife premenopausal women.

Official Title

Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women

Quick Facts

Study Start:2024-11-15
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06745466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age 40-55
  3. * Premenopausal
  1. * Pregnancy (including a positive urine pregnancy test), planning to become pregnant, or breast-feeding
  2. * Peri- or post-menopausal
  3. * Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease
  4. * Current or lifetime major psychiatric illness (e.g., major depressive disorder, bipolar disorder, schizophrenia, eating disorders)
  5. * History of hysterectomy (complete or partial), polycystic ovary syndrome, endometrial hyperplasia, irregular menstrual cycles, or endometrial ablation
  6. * Suspected potential presence of obstructive sleep apnea (STOP-Bang score \>3) or insomnia (Insomnia Severity Index score \>15)
  7. * Current or recent (within 8 wks) use of medications that could conceivably alter cardiovascular function or sleep health
  8. * Changes or alterations in medication status (starting a new, additional, or different medication or changing the dose of a current medication)
  9. * Body mass index \>35 kg/m2
  10. * Tobacco or nicotine use, including vaping and electronic cigarettes
  11. * Working night-time or rotating shift work within the previous 3 months
  12. * Trans-meridian travel during study enrollment (inclusive of the entire duration of enrollment and the period between testing cycles)
  13. * Known allergies to pharmacological agents/drugs
  14. * Current use of long-acting reversible contraception (LARC; e.g., IUDs, birth control implants)
  15. * Known latex allergy

Contacts and Locations

Study Contact

Jody Greaney, PhD
CONTACT
302-831-3181
jgreaney@udel.edu
Virginia Nuckols, PhD
CONTACT
gnuckols@udel.edu

Principal Investigator

Jody Greaney, PhD
PRINCIPAL_INVESTIGATOR
University of Delaware

Study Locations (Sites)

University of Delaware
Newark, Delaware, 19713
United States

Collaborators and Investigators

Sponsor: University of Delaware

  • Jody Greaney, PhD, PRINCIPAL_INVESTIGATOR, University of Delaware

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-15
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-11-15
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Premenopause
  • Estrogen
  • Stress
  • Sleep
  • Vascular function

Additional Relevant MeSH Terms

  • Estrogen
  • Premenopause