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Controlled Sleep for Menstrual Cycle-Related Sleep Deprivation

N/A

Recruiting

Led By Melissa A St. Hilaire, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Weight >110 lb

Must not have

Primary sleep disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effects of sleep loss on premenopausal women at different times in their menstrual cycle.

Who is the study for?

This trial is for healthy premenopausal women aged 18-35 with a BMI of 18.5-29.5 kg/m2 and weight over 110 lb. Participants should have regular menstrual cycles (26-35 days) and sleep patterns (7-9 hours/night), not use hormonal contraception for the past 3 months, or take any medications or supplements.

What is being tested?

The study examines how different sleep loss patterns affect healthy women at various stages of their menstrual cycle. It involves controlled sleep conditions to understand the impact on participants' responses during these times.

What are the potential side effects?

Since this trial involves controlled sleep rather than medication, there are no direct side effects like those from drugs; however, participants may experience tiredness or changes in mood due to altered sleeping patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I weigh more than 110 pounds.

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I am between 18 and 35 years old.

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I am not currently taking any medications or supplements.

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a primary sleep disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Core body temperature

KSS score

P4/E2 ratio

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Control sleep - luteal phaseExperimental Treatment1 Intervention

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.

Group II: Control sleep - follicular phaseExperimental Treatment1 Intervention

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.

Group III: Chronic variable sleep deficiency - luteal phaseExperimental Treatment1 Intervention

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.

Group IV: Chronic variable sleep deficiency - follicular phaseExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Controlled sleep

2020

N/A

~60

0 / 6Eligibility criteria met