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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Deprivation; Menstrual Cycle; Microbiota; Metabolism; Immune System; Brain Health
• Intervention / Treatment: Other: Investigate sleep deprivation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Benedict, PhD; Phone Number: +4618-471 4148; Email: christian.benedict@farmbio.uu.se
• Study Contact Backup: Name: Meth

Study Locations

• Sweden
  • Uppsala, Sweden, 751 23
    • Recruiting
    • Uppsala University
    • Contact: Christian Benedict, PhD; Email: christian.benedict@farmbio.uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep deprivation; All participants will undergo an 8-hour sleep opportunity, immediately followed by a night of total sleep deprivation.	Other: Investigate sleep deprivation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	2 years
The effects of sleep deprivation on glucose metabolism	Assessed with an Oral Glucose Tolerance Test (OGTT) and continuous blood glucose monitoring.	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.	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)	2 years
The effects of sleep deprivation on vaginal microbiota classification across the menstrual cycle	Classification of community state types (CST)	2 years
The effects of sleep deprivation on vaginal microbiota across the menstrual cycle	Changes in total phage content	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.	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.	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.	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.	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	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.	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.	2 years
The effects of sleep deprivation on appetite across the menstrual cycle	Blood analysis for leptin/ghrelin ratio	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.	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.	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.	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.	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.	4 years

Collaborators and Investigators

• Sponsor: Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Estrogen
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Dyssomnias; Sleep Deprivation
• Other Study ID Numbers: 2021-04191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No