Sleep DeprivationNCT05381532
Menstrual-phase-dependent Differences in Response to Sleep Loss
A study of Sleep Deprivation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 31 Mar 2026
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18-35 years old
- Regular menstrual cycle between 26-35 days in duration
- Not using any form of hormonal contraception for at least the prior 3 months
- Regular sleep patterns (7-9 hours/night)
- Not taking any medications or supplements
- Weight >110 lb
- BMI between 18.5 and 29.5 kg/m2
Who cannot join
- Primary sleep disorder
- History of shift work
- Transmeridian travel in the previous 3 months
- Presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders
- Current pregnancy, < 6 months postpartum, and/or breastfeeding
- Blood donation in the past 8 weeks
- Extreme morning or evening chronotype
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.
Read the detailed description
During a 1.5-week inpatient laboratory protocol, participants will undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle (4 study arms total). Subjects will be randomly assigned to each study arm. During their time in the laboratory, biological samples (e.g., blood) will be collected for assessment of sex steroid hormones and other analyses. Sleep quantity and quality will be monitored and responses on neurobehavioral tests and surveys will be monitored for differences across conditions.
- Conditions
- Sleep Deprivation
- Being tested
- Controlled sleep
- Keywords
- Sleep Restriction, Women's Health
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled sleepBehavioural
Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.
| Study group | Role | What they receive |
|---|---|---|
| Chronic variable sleep deficiency - follicular phase | Experimental | This will be the first of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. Receives: Behavioral: Controlled sleep |
| Chronic variable sleep deficiency - luteal phase | Experimental | This will be the second of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. Receives: Behavioral: Controlled sleep |
| Control sleep - follicular phase | Experimental | This will be the third of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. Receives: Behavioral: Controlled sleep |
| Control sleep - luteal phase | Experimental | This will be the fourth of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. Receives: Behavioral: Controlled sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVT mean reaction time
The mean reaction time will be calculated across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT mean reaction time at each time point (multiple points across the study) across all 4 study arms.
Measured: The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
PVT lapses in attention
The number of lapses in attention will be counted across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT lapses in attention at each time point (multiple points across the study) across all 4 study arms.
Measured: The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
KSS score
The Karolinska Sleepiness Score (KSS) measures level of sleepiness on a 9-point Likert scale with 1 = Extremely Alert and 9 = Extremely Sleepy. A linear mixed model analysis will be conducted to compare KSS score at each time point (multiple points across the study) across all 4 study arms.
Measured: The KSS will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
P4/E2 ratio
The ratio of progesterone (P4) and estradiol (E2) in each sample will be calculated as (P4 ng/ml x 1000)/E2 pg/ml. A linear mixed model analysis will be conducted to compare the P4/E2 ratio at each time point (multiple points across the study) across all 4 study arms.
Measured: Biological samples will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Core body temperature
Core body temperature is measured via rectal thermistor. A linear mixed model analysis will be conducted to compare the core body temperature at each time point (multiple points across the study) across all 4 study arms.
Measured: Core body temperature will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start17 Oct 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Melissa A. St. Hilaire, Ph.D, Brigham and Women's Hospital
- Investigators
- Melissa A St. Hilaire, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381532
- Sponsor's protocol ID
- 2021P002586
- Other IDs
- R01HL162102
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that form the basis of a peer-reviewed manuscript will be made available after publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual-phase-dependent Differences in Response to Sleep Loss
- ClinicalTrials.gov ID
- NCT05381532
- Acronym / sponsor ID
- 2021P002586
- Conditions
- Sleep Deprivation
- Keywords
- Sleep Restriction, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 19 May 2022 (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.
This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.
Detailed description
During a 1.5-week inpatient laboratory protocol, participants will undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle (4 study arms total). Subjects will be randomly assigned to each study arm. During their time in the laboratory, biological samples (e.g., blood) will be collected for assessment of sex steroid hormones and other analyses. Sleep quantity and quality will be monitored and responses on neurobehavioral tests and surveys will be monitored for differences across conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic variable sleep deficiency - follicular phase | Experimental | Behavioral: Controlled sleepThis will be the first of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. |
| Chronic variable sleep deficiency - luteal phase | Experimental | Behavioral: Controlled sleepThis will be the second of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. |
| Control sleep - follicular phase | Experimental | Behavioral: Controlled sleepThis will be the third of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. |
| Control sleep - luteal phase | Experimental | Behavioral: Controlled sleepThis will be the fourth of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female
- 18-35 years old
- Regular menstrual cycle between 26-35 days in duration
- Not using any form of hormonal contraception for at least the prior 3 months
- Regular sleep patterns (7-9 hours/night)
Key exclusion criteria (7 listed)
- Primary sleep disorder
- History of shift work
- Transmeridian travel in the previous 3 months
- Presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders
- Current pregnancy, < 6 months postpartum, and/or breastfeeding
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 |
|---|---|---|
| Controlled sleepDuration and timing of sleep will be assigned and monitored in a controlled laboratory environment. | Behavioural | Chronic variable sleep deficiency - follicular phase, Chronic variable sleep deficiency - luteal phase, Control sleep - follicular phase, Control sleep - luteal phase |
Primary outcome
PVT mean reaction time
Time frame: The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
The mean reaction time will be calculated across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT mean reaction time at each time point (multiple points across the study) across all 4 study arms.
PVT lapses in attention
Time frame: The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
The number of lapses in attention will be counted across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT lapses in attention at each time point (multiple points across the study) across all 4 study arms.
KSS score
Time frame: The KSS will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
The Karolinska Sleepiness Score (KSS) measures level of sleepiness on a 9-point Likert scale with 1 = Extremely Alert and 9 = Extremely Sleepy. A linear mixed model analysis will be conducted to compare KSS score at each time point (multiple points across the study) across all 4 study arms.
P4/E2 ratio
Time frame: Biological samples will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
The ratio of progesterone (P4) and estradiol (E2) in each sample will be calculated as (P4 ng/ml x 1000)/E2 pg/ml. A linear mixed model analysis will be conducted to compare the P4/E2 ratio at each time point (multiple points across the study) across all 4 study arms.
Core body temperature
Time frame: Core body temperature will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Core body temperature is measured via rectal thermistor. A linear mixed model analysis will be conducted to compare the core body temperature at each time point (multiple points across the study) across all 4 study arms.
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 2 Jul 2026.
- Individual participant dataSharing planned: Yes. Data that form the basis of a peer-reviewed manuscript will be made available after publication.
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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. This study is not recruiting at the moment.
Melissa A St. Hilaire, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sleep Deprivation, run by Brigham and Women's Hospital 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 8 inclusion and 7 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 2 Jul 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?
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.
What does the primary outcome measure?
PVT mean reaction time (time frame: The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.). The study lists 5 primary outcomes in all. 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 2 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.