Controlled Sleep for Menstrual Cycle-Related Sleep Deprivation
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications or supplements to participate in this trial.
Is controlled sleep therapy safe for humans?
Research on sleep deprivation techniques, which are similar to controlled sleep therapy, suggests they are generally safe for humans. These techniques have been used in treating mood disorders and premenstrual dysphoric disorder, with studies indicating they can be safely combined with other treatments like light therapy.12345
How does controlled sleep differ from other treatments for menstrual cycle-related sleep deprivation?
Controlled sleep, which involves managing sleep timing and duration, is unique because it targets the body's natural sleep-wake cycle and circadian rhythms (the body's internal clock) to improve sleep quality and reduce symptoms. Unlike other treatments that might focus on medication or lifestyle changes, this approach specifically aims to realign sleep patterns and enhance the body's natural sleep pressure, potentially offering a more direct and non-pharmacological solution.678910
What data supports the effectiveness of the treatment Controlled Sleep, Sleep Restriction Therapy, Sleep Compression Therapy, Stimulus Control Therapy for menstrual cycle-related sleep deprivation?
Research shows that Sleep Restriction Therapy (SRT) can effectively reduce the time it takes to fall asleep and improve sleep pressure, which may help with sleep issues related to the menstrual cycle. Additionally, sleep deprivation treatments have been shown to help correct circadian rhythm disturbances in conditions like premenstrual dysphoric disorder, suggesting potential benefits for menstrual cycle-related sleep problems.367810
Who Is on the Research Team?
Melissa A St. Hilaire, PhD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Laboratory Protocol
Participants undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle. Biological samples are collected, and sleep quantity and quality are monitored.
Follow-up
Participants are monitored for safety and effectiveness after the inpatient protocol
What Are the Treatments Tested in This Trial?
Interventions
- Controlled Sleep
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator