Menstrual-phase-dependent Differences in Response to Sleep Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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Menstrual-phase-dependent Differences in Response to Sleep Loss

Conditions
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Sleep Deprivation

Intervention / Treatment
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* Behavioral: Controlled sleep


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic variable sleep deficiency - follicular phase<br>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<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.<br>|
| Experimental: Chronic variable sleep deficiency - luteal phase<br>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<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.<br>|
| Experimental: Control sleep - follicular phase<br>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<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.<br>|
| Experimental: Control sleep - luteal phase<br>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<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Restriction, Women's Health