Body Clocks - Coordination of Peripheral and Central Oscillators

April 21, 2026 updated by: Jamie Zeitzer, Stanford University

Confluence of Sleep, Circadian Rhythms, and the Menstrual Cycle on Injury Risk in Women

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy young women with erratic schedules

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women
Young women with regular menstrual cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride time
Time Frame: 28 days
Duration of each stride
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: 28 days
Daily sleep duration determined through actigraphy
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Jamie M Zeitzer, PhD, Stanford University

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 Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-66230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be provided via Dryad, analytic code will be provided via Github

IPD Sharing Time Frame

IPD and supporting information will be made available after publication for an indefinite amount of time

IPD Sharing Access Criteria

Both Dryad and Github are fully open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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