Effects of sleep loss on women during different menstrual phases
Menstrual-phase-dependent Differences in Response to Sleep Loss
This study tests how losing sleep affects healthy women at different times in their menstrual cycle to see if their responses change based on hormonal levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05381532 on ClinicalTrials.gov |
What this trial studies
This study investigates how healthy premenopausal women respond to sleep deprivation at various stages of their menstrual cycle. Participants will be assigned to one of two sleep conditions during either the follicular or luteal phase, with a total of four study arms. Throughout a 1.5-week inpatient protocol, biological samples will be collected, and sleep patterns will be monitored alongside neurobehavioral assessments to identify differences in responses to sleep loss. The goal is to understand the interplay between sleep deprivation and hormonal fluctuations.
Who should consider this trial
Good fit: Ideal candidates are healthy premenopausal women aged 18-35 with regular menstrual cycles and sleep patterns.
Not a fit: Patients with primary sleep disorders, significant health issues, or those currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for sleep deprivation in women, tailored to their menstrual cycle.
How similar studies have performed: While studies on sleep and hormonal influences exist, this specific approach focusing on menstrual-phase-dependent responses to sleep loss is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * 18-35 years old * Regular menstrual cycle between 26-35 days in duration * Not using any form of hormonal contraception for at least the prior 3 months * Regular sleep patterns (7-9 hours/night) * Not taking any medications or supplements * Weight \>110 lb * BMI between 18.5 and 29.5 kg/m2 Exclusion Criteria: * Primary sleep disorder * History of shift work * Transmeridian travel in the previous 3 months * Presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders * Current pregnancy, \< 6 months postpartum, and/or breastfeeding * Blood donation in the past 8 weeks * Extreme morning or evening chronotype
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Melissa A St. Hilaire, PhD — Brigham and Women's Hospital
- Study coordinator: Melissa A St. Hilaire, PhD
- Email: msthilaire@rics.bwh.harvard.edu
- Phone: 6172780620
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.