Menstrual-phase-dependent Differences in Response to Sleep Loss

NCT05381532 | Recruiting DMC

• 2 other identifiers: 2021P002586R01HL162102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Keywords

Sleep Restriction; Women's Health

Outcome Measures

Primary Outcomes (5)

• PVT 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.

  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.

  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.

  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.

  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.

  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.

Study Arms (4)

Chronic variable sleep deficiency - follicular phase

EXPERIMENTAL

This will be the first of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.

Behavioral: Controlled sleep

Chronic variable sleep deficiency - luteal phase

EXPERIMENTAL

This will be the second of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.

Behavioral: Controlled sleep

Control sleep - follicular phase

EXPERIMENTAL

This will be the third of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.

Behavioral: Controlled sleep

Control sleep - luteal phase

EXPERIMENTAL

This will be the fourth of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.

Behavioral: Controlled sleep

Interventions

Controlled sleep BEHAVIORAL

Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.

Chronic variable sleep deficiency - follicular phase; Chronic variable sleep deficiency - luteal phase; Control sleep - follicular phase; Control sleep - luteal phase

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Melissa A St. Hilaire, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa A St. Hilaire, PhD

CONTACT

6172780620; msthilaire@rics.bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants may not know to which study arm they are assigned.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Biostatistician

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 19, 2022
• Study Start: October 17, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Release of data forming the basis of a peer-reviewed manuscript will be made available after publication. Release will be consistent with Institutional Review Board, journal, and federal requirements.
• Access Criteria: Access may be controlled, e.g., in accordance with the National Institutes of Health.

Locations

US (1)