Sleep DeprivationMENSLEEPNCT06683248
The Effects of Night Shift Work on Health Across the Menstrual Cycle
A study testing Investigate sleep deprivation in people with Sleep Deprivation and Menstrual Cycle, run by Uppsala University at 1 site in Sweden.
Trial summary
The study aims to investigate the effects of sleep deprivation on women's health across different phases of 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, Menstrual Cycle, Brain Health
- What is being tested?
- Investigate sleep deprivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 25 Apr 2022to 31 Dec 2025
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- Use of hormonal contraceptives
- Chronic disease
- Regular use of nicotine
- Use of medication
- Consumes excessive amounts of alcohol or coffee
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meth contact
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, Uppsala County, 751 23
Christian Benedict, PhD, christian.benedict@farmbio.uu.se
About this study
Official title: The Effects of Night Shift Work on Health Across the Menstrual Cycle: a Pilot Study
The study aims to investigate the effects of sleep deprivation on women's health across different phases of the menstrual cycle.
Read the detailed description
Modern society demands around-the-clock services, with an estimated 20% of workers involved in night shifts. Shift work disrupts the circadian rhythm and has been linked to increased risks of obesity, metabolic syndrome, glucose dysregulation, and immune system issues. Sleep deprivation, especially during wakeful nights, is associated with elevated levels of central nervous system biomarkers like Tau and Amyloid-β proteins, which are implicated in brain disorders such as Alzheimer's disease.
However, the effects of sleep deprivation on women, particularly in relation to hormonal fluctuations during the menstrual cycle, remain largely unexplored. The menstrual cycle, which occurs in cis-women of childbearing age, involves significant fluctuations in estrogen, a hormone known for its neuroprotective properties. Estrogen impacts memory, executive function, and may play a role in protecting against neurodegenerative conditions like Alzheimer's disease. Previous studies have largely focused on men or women using hormonal contraceptives, leaving a gap in understanding how natural hormonal cycles impact the response to sleep deprivation.
This study addresses this gap by focusing on healthy young women with regular menstrual cycles who do not use hormonal contraceptives. Participants will undergo an adaptation night followed by a sleep condition and a wake condition experiment. The goal is to better understand how hormonal changes throughout the menstrual cycle influence the body's response to sleep deprivation and stress, particularly in areas such as metabolism, brain function, and immune, system, and microbiota.
- Conditions
- Sleep Deprivation, Menstrual Cycle, Brain Health, Metabolism, Microbiota, Immune System
- Being tested
- Investigate sleep deprivation
- Keywords
- Estrogen
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigate sleep deprivationOther
Sleep deprivation
Devices used:
Dreem band for EEG Actiheart Tobii Eye tracker Blood glucose monitor Blood pressure cuff Mira fertility tracker Galvanic skin response K5: wearable metabolic system Fitbit: wearable technology Withings sleep analyzer Body composition monitor
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | All participants will undergo an 8-hour sleep opportunity, immediately followed by a night of total sleep deprivation. Receives: Other: Investigate sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of sleep deprivation vs sleep on brain health across the menstrual cycle
Blood analysis for neurodegenerative biomarkers, specifically Tau protein phosphorylated at amino acid 181 and 231, Aβ40 and Aβ42, GFAP, NfL.
Measured: 1 year
The effects of sleep deprivation across the menstrual cycle on EEG
The Dreem headband will be used to record EEG, assessing wakefulness levels during the sleep deprivation night through spectral power analysis. It will also be used to generate a hypnogram for sleep stage classification.
Measured: 1 year
The effects of sleep deprivation on metabolic function (TEE)
Energy Expenditure is measured with the K5 wearable system to monitor VO₂ and VCO₂ in real-time, assessing total energy expenditure (TEE).
Measured: 2 years
The effects of sleep deprivation on glucose metabolism
Assessed with an Oral Glucose Tolerance Test (OGTT) and continuous blood glucose monitoring.
Measured: 1 year
The effects of sleep deprivation on leptin/adiponectin ratio
Blood analysis to assess the ratio of leptin/adiponectin for metabolic health throughout the menstrual cycle.
Measured: 2 years
The effects of sleep deprivation on vaginal microbiota identification across the menstrual cycle
Identification and comparison of bacterial species composition and diversity (alpha- and beta-diversity)
Measured: 2 years
The effects of sleep deprivation on vaginal microbiota classification across the menstrual cycle
Classification of community state types (CST)
Measured: 2 years
The effects of sleep deprivation on vaginal microbiota across the menstrual cycle
Changes in total phage content
Measured: 2 years
The effect of sleep deprivation on stress response across the menstrual cycle
An auditory paradigm for stress induction will employ eye tracking to monitor changes in pupil dilation.
Measured: 2 years
The effect of sleep deprivation on stress response across the menstrual cycle
Galvanic skin response measures the electrical characteristics or conductance of the skin as an indirect measure of sympathetic autonomic activity using the change of electrical properties of skin measured continuously throughout an auditory paradigm designed to induce stress.
Measured: 2 years
The effect of sleep deprivation on stress response across the menstrual cycle
Heart rate is tracked to assess autonomic responses to stress throughout the auditory paradigm for stress induction.
Measured: 2 years
The effects of sleep deprivation on immune system profiling across menstrual cycle
Human blood samples are analyzed to determine the levels of proangiogenic neutrophils characterized as CD45+CD3-CD19-CD16+CD49d+VEGFR1+. Additionally, the presence of cytotoxic natural killer (NK) cells defined as CD56dim, CD16+, CX3CR1+, CCR7-, CXCR4dim, and CD57+, alongside non-cytotoxic NK cells, which are identified as CD56bright, CD16-, CX3CR1-, CCR7+, CXCR4 high, and CD57-. The cellular populations are expressed as a percentage of CD45+ positive cells, reflecting the total leukocyte population in the blood. To quantify these cell types, the leukocytes are isolated through gradient centrifugation and analyzed using spectral flow cytometry following incubation with two multicolor antibody panels.
The technique used is FACS, fluorescence-activated cell sorting.
Measured: 3 years
The levels of 6-sulfatoxymelatonin across the menstrual cycle during sleep and sleep deprivation conditions
Urine levels measured 6-sulfatoxymelatonin during both sleep and sleep deprivation condition
Measured: 2 years
The effects of sleep vs sleep deprivation on ABI across the menstrual cycle
Ankle-Brachial Index (ABI) assessed by comparing blood pressure in legs and arms.
Measured: 1 year
The effects of sleep deprivation on palatability across the menstrual cycle
Subjective rating of palatability for food items on a Visual Analogue Scale (VAS).
Scale Range: 0 to 100, with 0 indicating "not at all palatable" and 100 indicating "extremely palatable." Higher scores indicate greater palatability, potentially signaling increased appeal for certain foods/calories following sleep deprivation, typically viewed as an adverse outcome.
Measured: 2 years
The effects of sleep deprivation on appetite across the menstrual cycle
Blood analysis for leptin/ghrelin ratio
Measured: 2 years
The effects of sleep deprivation on food arousal across the menstrual cycle
Food arousal response will be assessed using an eye tracker to analyze changes in pupil dilation.
Measured: 2 years
The effects of sleep deprivation on hunger across the menstrual cycle
A portion size task is administered to the participant on the morning following both sleep and sleep deprivation conditions to assess hunger. Hunger will be measured by the total caloric content of food portions selected by the participant during the task.
Measured: 2 years
The effects of sleep deprivation on psychomotor vigilance across the menstrual cycle
The Psychomotor Vigilance Task (PVT) is a visual reaction time test used to objectively assess sustained attention and alertness. Participants respond as quickly as possible to visual stimuli, with mean reaction time and the number of lapses (missed responses) serving as key outcome measures that reflect cognitive performance, particularly in conditions like sleep deprivation or fatigue.
Measured: 2 years
The effect of salivary cortisol on sleep vs sleep deprivation across the menstrual cycle
Salivary cortisol samples will be collected during the sleep deprivation night and on the following morning after both sleep and sleep deprivation conditions to investigate cortisol levels in response to sleep loss across menstrual cycle.
Measured: 2 years
Oral microbiota changes across menstrual cycle and sleep deprivation
Analyze the changes in the oral microbiota across the menstrual cycle in sleep and sleep deprivation conditions by investigating shifts in microbial composition, diversity, and the abundance of bacteria. This could provide insights into how sleep patterns and menstrual phases interact to impact oral health.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start25 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Uppsala 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Benedict, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683248
- Sponsor's protocol ID
- 2021-04191
- Acronym
- MENSLEEP
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Night Shift Work on Health Across the Menstrual Cycle: a Pilot Study
- ClinicalTrials.gov ID
- NCT06683248
- Acronym / sponsor ID
- MENSLEEP / 2021-04191
- Conditions
- Sleep Deprivation, Menstrual Cycle, Brain Health, Metabolism, Microbiota, Immune System
- Keywords
- Estrogen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Nov 2024 (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 study aims to investigate the effects of sleep deprivation on women's health across different phases of the menstrual cycle.
Detailed description
Modern society demands around-the-clock services, with an estimated 20% of workers involved in night shifts. Shift work disrupts the circadian rhythm and has been linked to increased risks of obesity, metabolic syndrome, glucose dysregulation, and immune system issues. Sleep deprivation, especially during wakeful nights, is associated with elevated levels of central nervous system biomarkers like Tau and Amyloid-β proteins, which are implicated in brain disorders such as Alzheimer's disease.
However, the effects of sleep deprivation on women, particularly in relation to hormonal fluctuations during the menstrual cycle, remain largely unexplored. The menstrual cycle, which occurs in cis-women of childbearing age, involves significant fluctuations in estrogen, a hormone known for its neuroprotective properties. Estrogen impacts memory, executive function, and may play a role in protecting against neurodegenerative conditions like Alzheimer's disease. Previous studies have largely focused on men or women using hormonal contraceptives, leaving a gap in understanding how natural hormonal cycles impact the response to sleep deprivation.
This study addresses this gap by focusing on healthy young women with regular menstrual cycles who do not use hormonal contraceptives. Participants will undergo an adaptation night followed by a sleep condition and a wake condition experiment. The goal is to better understand how hormonal changes throughout the menstrual cycle influence the body's response to sleep deprivation and stress, particularly in areas such as metabolism, brain function, and immune, system, and microbiota.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Other: Investigate sleep deprivationAll participants will undergo an 8-hour sleep opportunity, immediately followed by a night of total sleep deprivation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (5 listed)
- Use of hormonal contraceptives
- Chronic disease
- Regular use of nicotine
- Use of medication
- Consumes excessive amounts of alcohol or coffee
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 |
|---|---|---|
| Investigate sleep deprivationSleep deprivation Devices used: Dreem band for EEG Actiheart Tobii Eye tracker Blood glucose monitor Blood pressure cuff Mira fertility tracker Galvanic skin response K5: wearable metabolic system Fitbit: wearable technology Withings sleep analyzer Body composition monitor | Other | Sleep deprivation |
Primary outcome
The effect of sleep deprivation vs sleep on brain health across the menstrual cycle
Time frame: 1 year
Blood analysis for neurodegenerative biomarkers, specifically Tau protein phosphorylated at amino acid 181 and 231, Aβ40 and Aβ42, GFAP, NfL.
The effects of sleep deprivation across the menstrual cycle on EEG
Time frame: 1 year
The Dreem headband will be used to record EEG, assessing wakefulness levels during the sleep deprivation night through spectral power analysis. It will also be used to generate a hypnogram for sleep stage classification.
The effects of sleep deprivation on metabolic function (TEE)
Time frame: 2 years
Energy Expenditure is measured with the K5 wearable system to monitor VO₂ and VCO₂ in real-time, assessing total energy expenditure (TEE).
The effects of sleep deprivation on glucose metabolism
Time frame: 1 year
Assessed with an Oral Glucose Tolerance Test (OGTT) and continuous blood glucose monitoring.
The effects of sleep deprivation on leptin/adiponectin ratio
Time frame: 2 years
Blood analysis to assess the ratio of leptin/adiponectin for metabolic health throughout the menstrual cycle.
The effects of sleep deprivation on vaginal microbiota identification across the menstrual cycle
Time frame: 2 years
Identification and comparison of bacterial species composition and diversity (alpha- and beta-diversity)
The effects of sleep deprivation on vaginal microbiota classification across the menstrual cycle
Time frame: 2 years
Classification of community state types (CST)
The effects of sleep deprivation on vaginal microbiota across the menstrual cycle
Time frame: 2 years
Changes in total phage content
The effect of sleep deprivation on stress response across the menstrual cycle
Time frame: 2 years
An auditory paradigm for stress induction will employ eye tracking to monitor changes in pupil dilation.
The effect of sleep deprivation on stress response across the menstrual cycle
Time frame: 2 years
Galvanic skin response measures the electrical characteristics or conductance of the skin as an indirect measure of sympathetic autonomic activity using the change of electrical properties of skin measured continuously throughout an auditory paradigm designed to induce stress.
The effect of sleep deprivation on stress response across the menstrual cycle
Time frame: 2 years
Heart rate is tracked to assess autonomic responses to stress throughout the auditory paradigm for stress induction.
The effects of sleep deprivation on immune system profiling across menstrual cycle
Time frame: 3 years
Human blood samples are analyzed to determine the levels of proangiogenic neutrophils characterized as CD45+CD3-CD19-CD16+CD49d+VEGFR1+. Additionally, the presence of cytotoxic natural killer (NK) cells defined as CD56dim, CD16+, CX3CR1+, CCR7-, CXCR4dim, and CD57+, alongside non-cytotoxic NK cells, which are identified as CD56bright, CD16-, CX3CR1-, CCR7+, CXCR4 high, and CD57-. The cellular populations are expressed as a percentage of CD45+ positive cells, reflecting the total leukocyte population in the blood. To quantify these cell types, the leukocytes are isolated through gradient centrifugation and analyzed using spectral flow cytometry following incubation with two multicolor antibody panels. The technique used is FACS, fluorescence-activated cell sorting.
The levels of 6-sulfatoxymelatonin across the menstrual cycle during sleep and sleep deprivation conditions
Time frame: 2 years
Urine levels measured 6-sulfatoxymelatonin during both sleep and sleep deprivation condition
The effects of sleep vs sleep deprivation on ABI across the menstrual cycle
Time frame: 1 year
Ankle-Brachial Index (ABI) assessed by comparing blood pressure in legs and arms.
The effects of sleep deprivation on palatability across the menstrual cycle
Time frame: 2 years
Subjective rating of palatability for food items on a Visual Analogue Scale (VAS). Scale Range: 0 to 100, with 0 indicating "not at all palatable" and 100 indicating "extremely palatable." Higher scores indicate greater palatability, potentially signaling increased appeal for certain foods/calories following sleep deprivation, typically viewed as an adverse outcome.
The effects of sleep deprivation on appetite across the menstrual cycle
Time frame: 2 years
Blood analysis for leptin/ghrelin ratio
The effects of sleep deprivation on food arousal across the menstrual cycle
Time frame: 2 years
Food arousal response will be assessed using an eye tracker to analyze changes in pupil dilation.
The effects of sleep deprivation on hunger across the menstrual cycle
Time frame: 2 years
A portion size task is administered to the participant on the morning following both sleep and sleep deprivation conditions to assess hunger. Hunger will be measured by the total caloric content of food portions selected by the participant during the task.
The effects of sleep deprivation on psychomotor vigilance across the menstrual cycle
Time frame: 2 years
The Psychomotor Vigilance Task (PVT) is a visual reaction time test used to objectively assess sustained attention and alertness. Participants respond as quickly as possible to visual stimuli, with mean reaction time and the number of lapses (missed responses) serving as key outcome measures that reflect cognitive performance, particularly in conditions like sleep deprivation or fatigue.
The effect of salivary cortisol on sleep vs sleep deprivation across the menstrual cycle
Time frame: 2 years
Salivary cortisol samples will be collected during the sleep deprivation night and on the following morning after both sleep and sleep deprivation conditions to investigate cortisol levels in response to sleep loss across menstrual cycle.
Oral microbiota changes across menstrual cycle and sleep deprivation
Time frame: 4 years
Analyze the changes in the oral microbiota across the menstrual cycle in sleep and sleep deprivation conditions by investigating shifts in microbial composition, diversity, and the abundance of bacteria. This could provide insights into how sleep patterns and menstrual phases interact to impact oral health.
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 14 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Meth contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigate sleep deprivation in people with Sleep Deprivation and Menstrual Cycle, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 5 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 14 Nov 2024. 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 Sweden. 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 Christian Benedict, PhD (+4618-471 4148, christian.benedict@farmbio.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of sleep deprivation vs sleep on brain health across the menstrual cycle (time frame: 1 year). The study lists 21 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 14 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.