Exploring alterations in sleep-related physiological and psychological outcomes across the menstrual cycle in young, healthy women without sleep disorders: a US-based pilot study protocol.
Level 5 - mechanism / opinion, no new human data
Study protocol without reported empirical data
PubMed 40701580 · doi:10.1136/bmjopen-2025-102698
What was done
This protocol describes a prospective pilot observational study evaluating sleep, metabolic, and psychological changes across two consecutive menstrual cycles in healthy, regularly menstruating premenopausal women aged 18 to 35 without sleep disorders. Sleep is tracked continuously using an FDA-approved diagnostic ring (SleepImage) and daily sleep diaries, complemented by two nights of home polysomnography to rule out undiagnosed sleep disorders. Daily morning urinary hormone concentrations (Mira Fertility Monitor) and biochemical assays confirm menstrual cycle phases. Body temperature, continuous blood glucose (Levels), physical activity, and resting vitals are monitored via wearables (including Oura), alongside assessments of mood, pain, and psychological distress. Primary endpoints are total sleep time and sleep quality; secondary endpoints include sleep onset latency, wakefulness after sleep onset, sleep architecture, heart rate variability, and daytime sleepiness.
What was found
The abstract reports no data or results; it presents only the study rationale, design, and methodology.
Why it matters
Understanding how endogenous hormonal fluctuations affect objective sleep architecture and subjective sleep quality may help clarify menstrual cycle-related variations in physical and mental well-being in reproductive-aged women.
Limits
This is a study protocol; no empirical results, effect sizes, or participant enrollment numbers (n) are reported. The intensive multi-device, daily collection protocol over two full menstrual cycles presents a high participant burden that may risk attrition or non-adherence. The inclusion criteria restrict enrollment to healthy women aged 18 to 35 with regular cycles and no sleep disorders, limiting applicability to individuals with irregular cycles, clinical insomnia, or hormonal disorders.
Cited by
- supports Prior scientific research examining sleep quality across the menstrual cycle is limited and relies predominantly on questionnaires or polysomnography measured across only a few isolated days.