Clinical trial NCT05381532: Menstrual-phase-dependent Differences in Response to Sleep Loss
Official title: Menstrual-phase-dependent Differences in Response to Sleep Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Deprivation
Keywords: Sleep Restriction
Women's Health
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-05-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female
* 18-35 years old
* Regular menstrual cycle between 26-35 days in duration
* Not using any form of hormonal contraception for at least the prior 3 months
* Regular sleep patterns (7-9 hours/night)
* Not taking any medications or supplements
* Weight \>110 lb
* BMI between 18.5 and 29.5 kg/m2

Exclusion Criteria:

* Primary sleep disorder
* History of shift work
* Transmeridian travel in the previous 3 months
* Presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders
* Current pregnancy, \< 6 months postpartum, and/or breastfeeding
* Blood donation in the past 8 weeks
* Extreme morning or evening chronotype

Primary outcomes:
measure: PVT mean reaction time
timeFrame: 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.
measure: PVT lapses in attention
timeFrame: 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.
measure: KSS score
timeFrame: 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.
measure: P4/E2 ratio
timeFrame: 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.
measure: Core body temperature
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Melissa A St. Hilaire, PhD
role: PRINCIPAL_INVESTIGATOR
References: