This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.
During a 1.5-week inpatient laboratory protocol, participants will undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle (4 study arms total). Subjects will be randomly assigned to each study arm. During their time in the laboratory, biological samples (e.g., blood) will be collected for assessment of sex steroid hormones and other analyses. Sleep quantity and quality will be monitored and responses on neurobehavioral tests and surveys will be monitored for differences across conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
100
Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGPVT mean reaction time
The mean reaction time will be calculated across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT mean reaction time at each time point (multiple points across the study) across all 4 study arms.
Time frame: The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
PVT lapses in attention
The number of lapses in attention will be counted across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT lapses in attention at each time point (multiple points across the study) across all 4 study arms.
Time frame: The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
KSS score
The Karolinska Sleepiness Score (KSS) measures level of sleepiness on a 9-point Likert scale with 1 = Extremely Alert and 9 = Extremely Sleepy. A linear mixed model analysis will be conducted to compare KSS score at each time point (multiple points across the study) across all 4 study arms.
Time frame: The KSS will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
P4/E2 ratio
The ratio of progesterone (P4) and estradiol (E2) in each sample will be calculated as (P4 ng/ml x 1000)/E2 pg/ml. A linear mixed model analysis will be conducted to compare the P4/E2 ratio at each time point (multiple points across the study) across all 4 study arms.
Time frame: Biological samples will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Core body temperature
Core body temperature is measured via rectal thermistor. A linear mixed model analysis will be conducted to compare the core body temperature at each time point (multiple points across the study) across all 4 study arms.
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Time frame: Core body temperature will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.