Shoonya Meditation for Sleep Deprivation

(REST Trial)

Overseen By Sepideh Hariri, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Cognition enhancers

Disqualifiers: Neurological, Psychiatric, Alcohol, Stroke, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 15-minute meditation practice affects sleep patterns, heart health, and mental performance after both good and bad nights of sleep. Participants will either learn and practice Shoonya meditation (a specific meditation technique), continue their regular napping habits, or serve as meditator controls. Suitable candidates are healthy adults living in the U.S. who can travel to Boston and either nap regularly or are interested in trying meditation. As an unphased trial, this study offers a unique opportunity to explore personal wellness through meditation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using cognition-enhancing medications.

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

Research shows that meditation practices, such as Shoonya meditation, are generally safe. Studies have not found any significant negative side effects from meditation. Shoonya meditation, which involves "conscious non-doing," aims to help individuals relax and sleep better.

The study on Shoonya meditation does not use medication or invasive methods, making it less likely to cause problems. As a natural practice, most people handle meditation well, and there are no reports of harmful effects from Shoonya meditation itself.

Overall, for those considering joining a trial involving Shoonya meditation, research suggests that the practice is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to combat sleep deprivation using meditation and nap practices. Shoonya Meditation is a unique approach that emphasizes "conscious non-doing," allowing the mind to settle naturally, which is quite different from the usual sleep aids like medication or cognitive behavioral therapy. Additionally, this trial investigates the benefits of Shukha Kriya Practice, which employs specific breathing exercises to prepare the body and mind for deeper relaxation. By examining these methods, researchers hope to uncover their potential to enhance sleep quality without relying on pharmaceuticals.

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

Research has shown that meditation practices, such as Shoonya Meditation, may help reduce the negative effects of insufficient sleep. In this trial, participants in the Shoonya Meditators arm will learn and practice Shoonya Meditation, a method of conscious relaxation that promotes calmness and mental well-being. Studies indicate that meditation can enhance sleep patterns and heart health, which often decline with inadequate sleep. Specifically, Shoonya Meditation has been linked to better brain health and improved cognitive skills. These benefits suggest that Shoonya Meditation could enhance sleep quality and mental alertness, even when sleep is limited. ^{1 2 3 6 7}

Who Is on the Research Team?

Balachundhar Subramaniam, MD, MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 living in the US who either practice Shoonya meditation or nap regularly. They must be able to travel to Boston and not have a history of psychiatric disorders, substance abuse, major neurological conditions, sleep disorders, heart issues, or consume excessive caffeine.

Inclusion Criteria

I am over 18, live in the US, nap often, and don't meditate.

I am over 18, live in the US, and can travel to Boston for a meditation program.

Exclusion Criteria

Pregnancy

I have a history of a neurological condition.

I am currently taking medication to improve my memory or thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Participants undergo baseline data collection including cognitive tests and polysomnography recording for sleep architecture and quality

1 weekend

1 visit (in-person)

Intervention

Shoonya Meditators practice meditation twice a day for two months; Control and Nap Practitioners continue their usual routine

2 months

Post-Intervention Data Collection

Intervention group undergoes data collection after 2 months of meditation practice; Control and Nap Practitioners undergo data collection at baseline

1 weekend

1 visit (in-person)

Follow-up

Participants are monitored for changes in cognitive performance and sleep architecture post-intervention

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Nap Practitioners
• Shoonya Meditation
• Shukha Kriya Practice

Trial Overview The study examines how a 15-minute Shoonya meditation affects sleep patterns and cognitive performance after both restful sleep and sleep deprivation compared to regular nappers. It also looks at changes in heart rate variability linked with high-frequency brain activity.

How Is the Trial Designed?

Group I: Control Meditators Active Control 1 Intervention

Control subjects will be individuals that have learned the prerequisite meditation to Shoonya meditation. This meditation is called Shambhavi Mahamudra Kriya. Control subjects will not learn Shoonya meditation while they are participating in the study. One weekend of data collection will occur at baseline.

Group II: Shoonya Meditators Active Control 1 Intervention

This is intervention arm. Participants will learn and practice the fifteen minute shoonya meditation - described as a process of conscious non-doing- and shakti chalana kriya, which is a set of breathing exercises designed as a preparatory practice to shoonya meditation. Participants will practice shoonya meditation twice a day for two months. A weekend of data collection will happen at baseline and two months after they learn the practice.

Group III: Nap Practitioners Placebo Group 1 Intervention

This is an observational arm of regular nappers. Individuals that take naps at least two times a week will be invited to undergo all of the study procedures for one weekend of data collection.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05026541

Study Details | NCT05026541 | Resilience to Sleep ... Meditation may be a means to mitigate the negative effects of sleep ... Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators.

2. withpower.com withpower.com/trial/phase-sleep-deprivation-10-2021-b0f2d

Shoonya Meditation for Sleep Deprivation (REST Trial) This trial investigates if regular meditation can help people who don't get enough sleep by improving heart function and relaxation.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05026541/resilience-to-sleep-deprivation-and-changes-in-sleep-architecture-in-shoonya-meditators

Resilience to Sleep Deprivation and Changes in ... This study aims to investigate the effect of a 15-minute meditation practice on sleep architecture and high-frequency Heart Rate Variability ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12170783/

Sleep-Based Brain Age Is Reduced in Advanced Inner ... Meditation seems to foster significant improvements in brain health, enhancing cognitive function and overall mental well-being (Luders et al., ...

5. alicantobidmc.org alicantobidmc.org/resources/resilience-sleep-deprivation-and-changes-sleep-architecture-shoonya-meditators

Resilience to Sleep Deprivation and Changes in ... Meditation may be a means to mitigate the negative effects of sleep deprivation, as many types of meditations are associated with increasing ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/44/NCT04366544/Prot_SAP_000.pdf

Effects of an 8-day Advanced Meditation, Samyama on ... 'Shoonya' meditation is an effortless process of conscious undoing. The ENOBIO EEG device is an FDA approved device under US federal law which is a 24- bit EEG ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05026541?keyword=%22Sleep%22

San Mateo Clinical Trial Resilience to Sleep Deprivation ... ~The investigators want to conduct a prospective cohort study where subjects are asked to learn and practice a 15-minute meditation (shoonya meditation) or ...