Circadian DysregulationNCT07459764
Body Clocks - Coordination of Peripheral and Central Oscillators
An observational study of Circadian Dysregulation, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Circadian Dysregulation
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy young women with erratic schedules
Who may be able to join
- Regular menstrual cycle (21-35 days)
- 18-30 years old
Who cannot join
- Neuromuscular or neurodegenerative disease
- Gut disorders
- circadian sleep disorders
- prescription medications affecting sleep
- recovering from physical injury
- taking hormonal birth control
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Lara Weed, weed@stanford.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Circadian Dysregulation
- Keywords
- sleep, circadian, menstrual, women's health
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women | Young women with regular menstrual cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride time
Duration of each stride
Measured: 28 days
Secondary outcomes (1)
Sleep
Daily sleep duration determined through actigraphy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Apr 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian DysregulationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Zeitzer, Stanford University
- Investigators
- Jamie M Zeitzer, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459764
- Sponsor's protocol ID
- IRB-66230
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be provided via Dryad, analytic code will be provided via Github
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confluence of Sleep, Circadian Rhythms, and the Menstrual Cycle on Injury Risk in Women
- ClinicalTrials.gov ID
- NCT07459764
- Acronym / sponsor ID
- IRB-66230
- Conditions
- Circadian Dysregulation
- Keywords
- sleep, circadian, menstrual, women's health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women | – | –Young women with regular menstrual cycles |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young women with erratic schedules
Key inclusion criteria (2 listed)
- Regular menstrual cycle (21-35 days)
- 18-30 years old
Key exclusion criteria (6 listed)
- Neuromuscular or neurodegenerative disease
- Gut disorders
- circadian sleep disorders
- prescription medications affecting sleep
- recovering from physical injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stride time
Time frame: 28 days
Duration of each stride
1 secondary outcome
Sleep
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be provided via Dryad, analytic code will be provided via Github
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie M Zeitzer, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Dysregulation, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara Weed, BS, MS (650-723-2300, weed@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride time (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.