Back to resultsMenstrual-phase-dependent Differences in Response to Sleep Loss
Primary Purpose
Sleep Deprivation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled sleep
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation focused on measuring Sleep Restriction, Women's Health
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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Chronic variable sleep deficiency - follicular phase
Chronic variable sleep deficiency - luteal phase
Control sleep - follicular phase
Control sleep - luteal phase
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05381532
First Posted
April 27, 2022
Last Updated
November 21, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05381532
Brief Title
Menstrual-phase-dependent Differences in Response to Sleep Loss
Official Title
Menstrual-phase-dependent Differences in Response to Sleep Loss
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
Sleep Restriction, Women's Health
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants may not know to which study arm they are assigned.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic variable sleep deficiency - follicular phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Chronic variable sleep deficiency - luteal phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Control sleep - follicular phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Control sleep - luteal phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Controlled sleep
Intervention Description
Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.
Primary Outcome Measure Information:
Title
PVT mean reaction time
Description
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.
Title
PVT lapses in attention
Description
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.
Title
KSS score
Description
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.
Title
P4/E2 ratio
Description
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.
Title
Core body temperature
Description
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.
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa A St. Hilaire, PhD
Phone
6172780620
Email
msthilaire@rics.bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa A St. Hilaire, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa A St Hilaire, Ph.D.
Phone
617-278-0620
Email
msthilaire@rics.bwh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data that form the basis of a peer-reviewed manuscript will be made available after publication.
IPD Sharing 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.
IPD Sharing Access Criteria
Access may be controlled, e.g., in accordance with the National Institutes of Health.
Learn more about this trial
Menstrual-phase-dependent Differences in Response to Sleep Loss
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