Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06683248

The Effects of Night Shift Work on Health Across the Menstrual Cycle

The study aims to investigate the effects of sleep deprivation on women's health across different phases of the menstrual cycle.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University

Uppsala, Uppsala County, 751 23, Sweden

Location status: Recruiting

Location contact

Christian Benedict, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy

Exclusion criteria

  • Use of hormonal contraceptives
  • Chronic disease
  • Regular use of nicotine
  • Use of medication
  • Consumes excessive amounts of alcohol or coffee

Treatment and study plan

Investigate sleep deprivation

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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)

  7. The effects of sleep deprivation on vaginal microbiota classification across the menstrual cycle

    Time frame: 2 years

    Classification of community state types (CST)

  8. The effects of sleep deprivation on vaginal microbiota across the menstrual cycle

    Time frame: 2 years

    Changes in total phage content

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. The effects of sleep deprivation on appetite across the menstrual cycle

    Time frame: 2 years

    Blood analysis for leptin/ghrelin ratio

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Benedict, PhD

CONTACT

[email protected]

+4618-471 4148

Meth

CONTACT

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

The Effects of Night Shift Work on Health Across the Menstrual Cycle: a Pilot Study

Acronym: MENSLEEP

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.