Menstrual-phase-dependent Differences in Response to Sleep Loss

Mass General Brigham

Status: Enrolling

Conditions: Sleep Deprivation

Treatments: Behavioral: Controlled sleep

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05381532

2021P002586

R01HL162102 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Chronic variable sleep deficiency - follicular phase

Experimental group

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.

Treatment:

Behavioral: Controlled sleep

Chronic variable sleep deficiency - luteal phase

Experimental group

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.

Treatment:

Behavioral: Controlled sleep

Control sleep - follicular phase

Experimental group

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.

Treatment:

Behavioral: Controlled sleep

Control sleep - luteal phase

Experimental group

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.

Treatment:

Behavioral: Controlled sleep