Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging … (NCT06745466) | Clinical Trial Compass
RecruitingPhase 4
Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
United States30 participantsStarted 2024-11-15
Plain-language summary
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.
Who can participate
Age range40 Years – 55 Years
SexFEMALE
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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)
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What they're measuring
1
Endothelium-dependent dilation (EDD)
Timeframe: Immediately before and after each 10-day measurement burst