What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Meditation practices, such as mindfulness-based stress reduction (MBSR), are generally considered safe and have few side effects. However, some individuals may experience increased anxiety, emotional discomfort, or agitation, especially during the initial stages of practice. These effects are usually temporary and diminish with continued practice. Other potential side effects include physical discomfort from prolonged sitting and, in rare cases, exacerbation of pre-existing psychiatric conditions. Overall, meditation is well-tolerated and beneficial for managing sleep deprivation and stress.

What prior FDA approvals exist?

The FDA has approved several treatments for sleep deprivation, primarily focusing on pharmacological interventions such as sedative-hypnotics (e.g., zolpidem, eszopiclone) and wakefulness-promoting agents (e.g., modafinil, armodafinil). While these medications are effective, non-pharmacological approaches like cognitive-behavioral therapy for insomnia (CBT-I) are also recognized for their efficacy. Meditation practices, known for their calming and stress-reducing effects, align with the principles of CBT-I, which emphasizes relaxation techniques and stress management to improve sleep quality. Although specific FDA approvals for meditation as a treatment are not documented, its benefits are supported by clinical guidelines and research in sleep medicine.

What other types of research exist?

Promising alternatives to meditation for sleep deprivation patients include music therapy, which has been shown to reduce anxiety and improve physiological responses in various clinical settings. Additionally, guided imagery and progressive muscle relaxation have demonstrated effectiveness in reducing pain and anxiety, which can be beneficial for improving sleep quality.

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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

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

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.

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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.