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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 weeks
Treatment ~ Varies
Follow Up ~2 months post learning meditation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months post learning meditation for reporting.

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.
A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects.

Find a Location

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

Media Library

Shoonya Meditators Clinical Trial Eligibility Overview. Trial Name: NCT05026541 — N/A
Sleep Deprivation Research Study Groups: Control Meditators, Shoonya Meditators, Nap Practitioners
Sleep Deprivation Clinical Trial 2023: Shoonya Meditators Highlights & Side Effects. Trial Name: NCT05026541 — N/A
Shoonya Meditators 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026541 — N/A
~4 spots leftby Dec 2024