100 Participants Needed

Controlled Sleep for Menstrual Cycle-Related Sleep Deprivation

MA
Overseen ByMelissa A St. Hilaire, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

MA

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

I am female.
I weigh more than 110 pounds.
Not using any form of hormonal contraception for at least the prior 3 months
See 4 more

Exclusion Criteria

I have a condition like diabetes, a metabolic disorder, or a psychiatric illness.
You have traveled across multiple time zones in the past 3 months.
I have been diagnosed with a primary sleep disorder.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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.

1.5 weeks
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after the inpatient protocol

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Controlled Sleep
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Control sleep - luteal phaseExperimental Treatment1 Intervention
Group II: Control sleep - follicular phaseExperimental Treatment1 Intervention
Group III: Chronic variable sleep deficiency - luteal phaseExperimental Treatment1 Intervention
Group IV: Chronic variable sleep deficiency - follicular phaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

Sleep restriction therapy (SRT) has been used for over 30 years to treat insomnia, but a systematic review of 15 studies revealed that while SRT effectively reduces time in bed and sleep onset latency, the underlying mechanisms of how it works remain poorly understood and inadequately tested.
The review highlighted that most studies showed improvements in sleep outcomes, but they did not specifically investigate whether changes in hypothesized mechanisms, like increased sleep pressure or reduced arousal, directly mediate these outcomes, indicating a need for more focused research on SRT's mechanisms.
How does sleep restriction therapy for insomnia work? A systematic review of mechanistic evidence and the introduction of the Triple-R model.Maurer, LF., Espie, CA., Kyle, SD.[2021]
In a study of 23 patients with premenstrual dysphoric disorder (PMDD) and 18 normal comparison subjects, sleep EEG measures showed significant differences based on menstrual cycle phases, with both groups experiencing less REM sleep during the luteal phase compared to the follicular phase.
Recovery sleep after sleep deprivation improved sleep quality in PMDD patients compared to normal subjects, suggesting that sleep deprivation may help address circadian rhythm disturbances in PMDD, although the specific sleep changes did not directly correlate with clinical improvement.
Sleep EEG studies during early and late partial sleep deprivation in premenstrual dysphoric disorder and normal control subjects.Parry, BL., Mostofi, N., LeVeau, B., et al.[2019]
Sleep restriction therapy (SRT) is as effective as cognitive behavioral therapy for insomnia (CBT-I) in treating insomnia in postmenopausal women, with fewer sessions required, making it a viable alternative for those unable to complete CBT-I.
Both SRT and CBT-I do not significantly increase the risk of excessive sleepiness compared to a sleep education control, indicating that SRT is a safe treatment option without unique concerns for sleepiness.
Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial.Cheng, P., Kalmbach, D., Fellman-Couture, C., et al.[2021]

Citations

How does sleep restriction therapy for insomnia work? A systematic review of mechanistic evidence and the introduction of the Triple-R model. [2021]
Sleep EEG studies during early and late partial sleep deprivation in premenstrual dysphoric disorder and normal control subjects. [2019]
Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial. [2021]
Self-reported sleep across the menstrual cycle in young, healthy women. [2015]
Temperature circadian rhythms during the menstrual cycle and sleep deprivation in premenstrual dysphoric disorder and normal comparison subjects. [2017]
A multistage chronobiologic intervention for the treatment of depression: a pilot study. [2009]
Sleep deprivation in mood disorders. [2022]
[Sleep deprivation and continuous sleep treatment for depression]. [2011]
Menstrual disturbances and its association with sleep disturbances: a systematic review. [2023]
Menstrual regularity and bleeding is associated with sleep duration, sleep quality and fatigue in a community sample. [2022]
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