Controlled Sleep for Menstrual Cycle-Related Sleep Deprivation

Overseen By Melissa A St. Hilaire, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Any medications

Disqualifiers: Primary sleep disorder, Diabetes, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep loss affects healthy women at different times in their menstrual cycle. Researchers aim to understand how changes in sleep patterns during the follicular and luteal phases impact daily life. The trial includes various sleep schedules, such as Controlled Sleep (also known as Sleep Restriction Therapy, Sleep Compression Therapy, or Stimulus Control Therapy), to uncover these effects. Women with regular periods, not on hormonal birth control, and who sleep 7-9 hours a night might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on sleep and menstrual health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that controlled sleep and similar sleep deprivation methods are generally safe. Studies suggest that sleep restriction therapy, akin to controlled sleep, has a safety profile similar to CBT-I, a common insomnia treatment, indicating it is usually well-tolerated.

Some studies note that sleep restriction therapy can increase daytime sleepiness. However, its overall safety record remains strong, making it a reasonable option for managing sleep patterns without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Controlled Sleep trial because it explores how manipulating sleep schedules during different phases of the menstrual cycle can impact sleep deprivation. Unlike traditional treatments for menstrual cycle-related sleep issues, which might focus on medication or lifestyle changes, this approach targets sleep patterns directly. By studying both control and chronic variable sleep deficiency schedules in the follicular and luteal phases, researchers hope to uncover insights into how sleep timing and quality can be optimized specifically around the menstrual cycle. This could offer a tailored, non-invasive method to improve sleep without relying on medication.

What evidence suggests that this trial's treatments could be effective for menstrual cycle-related sleep deprivation?

Research has shown that sleep treatments can improve sleep. Studies have found that sleep restriction therapy, which limits sleep time, can moderately reduce depression symptoms. Both sleep restriction and sleep compression therapies effectively treat insomnia, with sleep restriction being slightly more effective. This trial will explore the effects of controlled sleep manipulation on sleep issues related to the menstrual cycle. Participants will be randomized into different arms, including control sleep and chronic variable sleep deficiency, during either the follicular or luteal phase of their menstrual cycle. The effects of these controlled sleep schedules are not fully understood yet, but early research appears promising. ^{1 6 7 8 9}

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

I am female.

I weigh more than 110 pounds.

Not using any form of hormonal contraception for at least the prior 3 months

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.

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?

Group I: Control sleep - luteal phase Experimental Treatment 1 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 phase Experimental Treatment 1 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 phase Experimental Treatment 1 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 phase Experimental Treatment 1 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.

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 deprivation (SD) is emerging as a safe and effective first-line treatment for mood disorders, supported by growing clinical evidence and biological mechanisms of action.

SD can be administered in various ways—total or partial, single or repeated sessions—and can be combined with other treatments like antidepressants and light therapy, making it a versatile option for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep deprivation in mood disorders. Benedetti, F., Colombo, C.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The new chronobiologic multistage intervention (CMI) showed a clinically significant and rapid improvement in depressive symptoms among moderate-to-severe depressive patients, with effects lasting at least 4 weeks after the intervention.

The intervention was well tolerated with high patient satisfaction and no dropouts, indicating it is a safe and effective alternative to traditional antidepressants, although further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multistage chronobiologic intervention for the treatment of depression: a pilot study. Moscovici, L., Kotler, M.[2009]

In a study of 579 menstruating females, short sleep duration was linked to heavier menstrual bleeding and greater cycle irregularity, suggesting that sleep patterns can significantly impact menstrual health.

Poor sleep quality and higher fatigue levels were also associated with menstrual irregularities and heavier bleeding, indicating that addressing sleep issues may be important for improving menstrual health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual regularity and bleeding is associated with sleep duration, sleep quality and fatigue in a community sample. Kennedy, KER., Onyeonwu, C., Nowakowski, S., et al.[2022]

In a study of 26 healthy, young women, subjective sleep quality was reported to be lower during the 3 days before menstruation and the 4 days of menstruation compared to other phases of the menstrual cycle.

Despite changes in perceived sleep quality, the menstrual cycle did not affect actual sleep continuity, such as total sleep time or awakenings, suggesting that sleep complaints may be more about perception than actual sleep disruption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported sleep across the menstrual cycle in young, healthy women. Baker, FC., Driver, HS.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Total sleep deprivation (TSD) can lead to significant but temporary improvements in severe depression, as observed in a study of 8 patients, where 3 showed a 50% reduction in depression scores after TSD.

The study found that non-responders to TSD had a higher minimum rectal temperature during the treatment night compared to their baseline, suggesting that temperature regulation may play a role in the effectiveness of sleep interventions for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sleep deprivation and continuous sleep treatment for depression]. Inoue, M., Nakamura, J.[2011]

Premenstrual dysphoric disorder (PMDD) subjects exhibit altered circadian rhythms of core body temperature, with decreased temperature amplitudes during the luteal phase compared to normal comparison (NC) subjects, indicating a potential physiological marker for PMDD.

Sleep deprivation interventions, such as early night partial sleep deprivation (ESD) and late night partial sleep deprivation (LSD), can normalize these temperature rhythms in PMDD subjects, suggesting that adjusting sleep patterns may have therapeutic benefits for managing PMDD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temperature circadian rhythms during the menstrual cycle and sleep deprivation in premenstrual dysphoric disorder and normal comparison subjects. Parry, BL., LeVeau, B., Mostofi, N., et al.[2017]

A systematic review of 35 studies found that menstrual disturbances, such as premenstrual syndrome and dysmenorrhea, are significantly associated with various sleep disturbances, including poor sleep quality and daytime sleepiness.

The findings suggest that improving sleep health could be beneficial for women experiencing menstrual disturbances, highlighting the need for future research to explore these associations further and develop targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual disturbances and its association with sleep disturbances: a systematic review. Jeon, B., Baek, J.[2023]

Citations

1. withpower.com withpower.com/trial/phase-sleep-deprivation-5-2022-d0f40

Controlled Sleep for Menstrual Cycle-Related ... The review highlighted that most studies showed improvements in sleep outcomes, but they did not specifically investigate whether changes in hypothesized ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11596993/

The effect of single‐component sleep restriction therapy on ... Findings suggest that sleep restriction therapy is associated with a medium effect for improvement in depressive symptoms at post‐treatment.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05561829

NCT05561829 | Determination of Optimal Sleep Treatment ... Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to ...

4. academic.oup.com academic.oup.com/sleep/article/48/8/zsaf093/8109686

Is sleep compression therapy non-inferior to sleep restriction ... In a large, rigorously controlled trial, both therapies improved insomnia, but sleep compression was less effective than sleep restriction in treating insomnia ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0140673623006839

Clinical and cost-effectiveness of nurse-delivered sleep ... Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7053018/

Risk of excessive sleepiness in sleep restriction therapy and ... SRT appears to have a comparable risk profile for excessive sleepiness as CBT-I, and thus may be considered a safe alternative to CBT-I.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04975776

Sleep Restriction Therapy for Insomnia in Primary Health ... Study outcomes include insomnia severity, sleep, daytime symptoms, quality of life, use of hypnotics, sick leave, and work ability. Outcomes will be assessed ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001284

Network meta-analysis examining efficacy of components ... Overall, the results suggest that sleep restriction therapy improves self-reported sleep continuity and sleep quality, and stimulus control therapy improves ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3900612/

Sleep Restriction Therapy for Insomnia is Associated with ... We show that acute sleep restriction therapy is associated with reduced objective total sleep time, increased daytime sleepiness, and objective performance ...