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Shoonya Meditation for Sleep Deprivation (REST Trial)
N/A
Recruiting
Led By Balachundhar Subramaniam, MD, MPH
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months post learning meditation
Awards & highlights
Summary
This trial investigates if regular meditation can help people who don't get enough sleep by improving heart function and relaxation. The study will compare cognitive performance and sleep quality between those who meditate and those who don't.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves meditation practices and napping without any pharmaceutical intervention, there are no direct side effects associated with these activities as they are generally considered safe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months post learning meditation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months post learning meditation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Error frequency Change: Go-No Go Task
Secondary study objectives
Reaction Time Change: Go-No Go
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Control MeditatorsActive Control1 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 MeditatorsActive Control1 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 PractitionersPlacebo Group1 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for sleep deprivation, such as meditation practices, work primarily by reducing stress and promoting relaxation. Meditation, including mindfulness-based stress reduction (MBSR), helps patients focus on the present moment, which decreases arousal and sympathetic activity, leading to lower heart rates and blood pressure.
This relaxation response can improve sleep quality by reducing the time it takes to fall asleep and increasing total sleep time. For sleep-deprived patients, these mechanisms are crucial as they address the underlying stress and anxiety that often exacerbate sleep issues, thereby promoting better sleep architecture and overall well-being.
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
852 Previous Clinical Trials
12,930,433 Total Patients Enrolled
6 Trials studying Sleep Deprivation
4,434 Patients Enrolled for Sleep Deprivation
Balachundhar Subramaniam, MD, MPHPrincipal InvestigatorBeth Israel Deaconess Medical Center
8 Previous Clinical Trials
9,939 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of a neurological condition.I am currently taking medication to improve my memory or thinking.I have not had a psychiatric disorder in the last 5 years.I have not abused alcohol or drugs in the last 5 years.I have had a stroke or aneurysm in the last 5 years.I am over 18, live in the US, nap often, and don't meditate.I have learned shoonya meditation before.I do not speak English.I have been diagnosed with a sleep disorder.I am over 18, live in the US, and can travel to Boston for a meditation program.I am 60 years old or older.I have had a seizure in the last 3 months.I drink 3 or more cups of coffee daily.I have had a heart attack and my heart's pumping ability is very low.
Research Study Groups:
This trial has the following groups:- Group 1: Control Meditators
- Group 2: Shoonya Meditators
- Group 3: Nap Practitioners
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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