Clinical trial NCT06683248: The Effects of Night Shift Work on Health Across the Menstrual Cycle
Official title: The Effects of Night Shift Work on Health Across the Menstrual Cycle: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Deprivation
Menstrual Cycle
Brain Health
Metabolism
Microbiota
Immune System
Keywords: Estrogen
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of sleep deprivation vs sleep on brain health across the menstrual cycle
timeFrame: 1 year
measure: The effects of sleep deprivation across the menstrual cycle on EEG
timeFrame: 1 year
measure: The effects of sleep deprivation on metabolic function (TEE)
timeFrame: 2 years
measure: The effects of sleep deprivation on glucose metabolism
timeFrame: 1 year
measure: The effects of sleep deprivation on leptin/adiponectin ratio
timeFrame: 2 years
measure: The effects of sleep deprivation on vaginal microbiota identification across the menstrual cycle
timeFrame: 2 years
measure: The effects of sleep deprivation on vaginal microbiota classification across the menstrual cycle
timeFrame: 2 years
measure: The effects of sleep deprivation on vaginal microbiota across the menstrual cycle
timeFrame: 2 years
measure: The effect of sleep deprivation on stress response across the menstrual cycle
timeFrame: 2 years
measure: The effect of sleep deprivation on stress response across the menstrual cycle
timeFrame: 2 years
measure: The effect of sleep deprivation on stress response across the menstrual cycle
timeFrame: 2 years
measure: The effects of sleep deprivation on immune system profiling across menstrual cycle
timeFrame: 3 years
measure: The levels of 6-sulfatoxymelatonin across the menstrual cycle during sleep and sleep deprivation conditions
timeFrame: 2 years
measure: The effects of sleep vs sleep deprivation on ABI across the menstrual cycle
timeFrame: 1 year
measure: The effects of sleep deprivation on palatability across the menstrual cycle
timeFrame: 2 years
measure: The effects of sleep deprivation on appetite across the menstrual cycle
timeFrame: 2 years
measure: The effects of sleep deprivation on food arousal across the menstrual cycle
timeFrame: 2 years
measure: The effects of sleep deprivation on hunger across the menstrual cycle
timeFrame: 2 years
measure: The effects of sleep deprivation on psychomotor vigilance across the menstrual cycle
timeFrame: 2 years
measure: The effect of salivary cortisol on sleep vs sleep deprivation across the menstrual cycle
timeFrame: 2 years
measure: Oral microbiota changes across menstrual cycle and sleep deprivation
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
References: