SleepNCT00456222
Impact of Sleep Disruption on the Menstrual Cycle
An observational study of Sleep and Circadian Rhythm, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing 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
- Sleep, Circadian Rhythm, Menstrual Cycle
- What is being tested?
- Disrupting or changing the timing or the duration of sleep
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2003to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 women with regular menstrual cycles
Who may be able to join
- Healthy
- Regular menstrual cycles
Who cannot join
- No medications affecting the menstrual cycle or sleep
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing
Read the detailed description
Menstrual cycle dynamics were studied after sleep disruption
- Conditions
- Sleep, Circadian Rhythm, Menstrual Cycle
- Being tested
- Disrupting or changing the timing or the duration of sleep
- Keywords
- Sleep, Circadian rhythms, Menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disrupting or changing the timing or the duration of sleepBehavioural
Disrupting or changing the timing or the duration of sleep
| Study group | Role | What they receive |
|---|---|---|
| Luteal | Not described Receives: Behavioral: Disrupting or changing the timing or the duration of sleep | |
| Follicular | Not described Receives: Behavioral: Disrupting or changing the timing or the duration of sleep |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startJun 2003
- Primary completionJul 2007
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Elizabeth B Klerman, MD PhD, Principal investigator, Brigham and Women's HospitalJanet E Hall, MD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456222
- Sponsor's protocol ID
- R01HD040291
- Other IDs
- NIH R01-HD40291
- Status last verified
- Aug 2009
- First submitted
- 2 Apr 2007
- Last updated
- 21 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Disruption on the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT00456222
- Acronym / sponsor ID
- R01HD040291
- Conditions
- Sleep, Circadian Rhythm, Menstrual Cycle
- Keywords
- Sleep, Circadian rhythms, Menstrual cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Apr 2007 (estimated)
- 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 purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing
Detailed description
Menstrual cycle dynamics were studied after sleep disruption
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luteal | – | Behavioral: Disrupting or changing the timing or the duration of sleep |
| Follicular | – | Behavioral: Disrupting or changing the timing or the duration of sleep |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women with regular menstrual cycles
Key inclusion criteria (2 listed)
- Healthy
- Regular menstrual cycles
Key exclusion criteria (1 listed)
- No medications affecting the menstrual cycle or sleep
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disrupting or changing the timing or the duration of sleepDisrupting or changing the timing or the duration of sleep | Behavioural | Follicular, Luteal |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2009.
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Healthy Adult Participants
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. This study is not recruiting at the moment.
Elizabeth B Klerman, MD PhD principal investigator
Brigham and Women's Hospital
Janet E Hall, MD study director
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Circadian Rhythm, run by Brigham and Women's Hospital at 2 sites 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 1 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: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 21 Aug 2009.