Body Clocks - Coordination of Peripheral and Central Oscillators
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Circadian Dysregulation. Basic parameters: 18 years — 30 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Confluence of Sleep, Circadian Rhythms, and the Menstrual Cycle on Injury Risk in Women
Overview
The investigators are conducting an observational trial examining young women over the course of 28 days in which we are monitoring movement, sleep, heart rate, oxygen saturation, gut physiology, light, and menstrual cycle. The inter- and independence of the cyclicity of these variables with each other, the circadian cycle, the menstrual cycle, and the sleep cycle will be tested.
Detailed description
For 28 days, women will wear devices to capture: ambient light exposure, lower limb biomechanics, sleep, oxygen saturation, heart rate, temperature, and gut physiology.
Twice during the study, women will have saliva collected for 7 hours under dim light conditions in order to determine melatonin concentrations. During this 7-hour period, two blood draws for determination of proteomic profiles will also occur.
Daily urine samples will be tested for LH until the presence of the LH surge to help identify menstrual phase.
Primary outcome measures
- Stride time [Time frame: 28 days]
Secondary outcome measures (1)
- Sleep [Time frame: 28 days]
Eligibility criteria
Inclusion criteria
- Regular menstrual cycle (21-35 days)
- 18-30 years old
Exclusion criteria
- Neuromuscular or neurodegenerative disease
- Gut disorders
- circadian sleep disorders
- prescription medications affecting sleep
- recovering from physical injury
- taking hormonal birth control
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT07459764 · IRB-66230