Uppsala University
Uppsala, Uppsala County, 751 23, Sweden
Location status: Recruiting
NCT Number: NCT06683248
The study aims to investigate the effects of sleep deprivation on women's health across different phases of the menstrual cycle.
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Not applicable
Uppsala, Uppsala County, 751 23, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 year
Blood analysis for neurodegenerative biomarkers, specifically Tau protein phosphorylated at amino acid 181 and 231, Aβ40 and Aβ42, GFAP, NfL.
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.
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).
Time frame: 1 year
Assessed with an Oral Glucose Tolerance Test (OGTT) and continuous blood glucose monitoring.
Time frame: 2 years
Blood analysis to assess the ratio of leptin/adiponectin for metabolic health throughout the menstrual cycle.
Time frame: 2 years
Identification and comparison of bacterial species composition and diversity (alpha- and beta-diversity)
Time frame: 2 years
Classification of community state types (CST)
Time frame: 2 years
Changes in total phage content
Time frame: 2 years
An auditory paradigm for stress induction will employ eye tracking to monitor changes in pupil dilation.
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.
Time frame: 2 years
Heart rate is tracked to assess autonomic responses to stress throughout the auditory paradigm for stress induction.
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.
Time frame: 2 years
Urine levels measured 6-sulfatoxymelatonin during both sleep and sleep deprivation condition
Time frame: 1 year
Ankle-Brachial Index (ABI) assessed by comparing blood pressure in legs and arms.
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.
Time frame: 2 years
Blood analysis for leptin/ghrelin ratio
Time frame: 2 years
Food arousal response will be assessed using an eye tracker to analyze changes in pupil dilation.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Uppsala University
Other
The Effects of Night Shift Work on Health Across the Menstrual Cycle: a Pilot Study
Acronym: MENSLEEP
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.
NCT06075914
Dyssomnias, Mental Disorders
Columbus, Ohio, United States
View Trial DetailsNCT07438912
Behavior, Behavioral Symptoms
Tucson, Arizona, United States
View Trial DetailsNCT05551325
Chronobiology Disorders, Circadian Rhythm Sleep Disorder, Unspecified
New Haven, Connecticut, United States
View Trial DetailsNCT06679543
Dyssomnias, Mental Disorders
Guelph, Ontario, Canada
View Trial Details