Menstrual-phase-dependent Differences in Response to Sleep Loss

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05381532
Status
Recruiting
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Conditions

  • Sleep Deprivation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Controlled sleep — BEHAVIORAL
    Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.

Study Details

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

Key Dates

Start date
Oct 17, 2022
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Chronic variable sleep deficiency - follicular phase
    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.
  • Experimental: Chronic variable sleep deficiency - luteal phase
    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.
  • Experimental: Control sleep - follicular phase
    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.
  • Experimental: Control sleep - luteal phase
    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.

Primary Outcome Measure

PVT mean reaction time [ 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Melissa A St Hilaire, Ph.D.
[email protected]
6172780620

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By research site
Brigham and Women's Hospital· Boston, MA

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