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Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators (REST)

Primary Purpose

Sleep, Sleep Deprivation, Cognitive Change

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nap Practitioners

Shoonya Meditation

About this trial

This is an interventional other trial for Sleep focused on measuring sleep, sleep disorder, sleep deprivation, Meditation, Shoonya meditation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Shoonya meditation program participants/individuals eligible to participate who are healthy adults of age 18 or older, and reside in Massachusetts. Participants must be able and willing to travel to Boston.
Nap Group: Healthy adults of age 18 or older that reside in the United States, nap regularly (at least 3 times a week), and do not meditate regularly.

Exclusion Criteria:

History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis)
History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder)
Current use of cognition enhancing medications
Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week)
History (within the last 5 years) of stroke/aneurysm
Recent history (< 3 months) of seizures
60 years of age or older
History of Heart Attack and Ejection Fraction less than or equal to 30%
Pregnancy
Non-English speaking
History/Diagnosis of any sleep disorder
Consumption of 3 or more cups of coffee a day
Previously learned shoonya meditation (for the meditator groups)

Sites / Locations

Beth Israel Deaconess Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

No Intervention

Arm Label

Nap Practitioners

Shoonya Meditators

Control Meditators

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Error frequency Change: Go-No Go Task

The primary outcome is the difference in number of commission and omission errors on the Go-No Go task. The difference in scores pre- and post-sleep deprivation will be analyzed between the control and intervention group.

Secondary Outcome Measures

Reaction Time Change: Go-No Go

The difference in reaction times on the Go-No Go task. The difference in scores pre- and post-sleep deprivation will compared between the control and intervention groups.

Full Information

NCT ID

NCT05026541

First Posted

July 19, 2021

Last Updated

September 18, 2023

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05026541

Brief Title

Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators

Acronym

REST

Official Title

Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 12, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to investigate the effect of a 15-minute meditation practice on sleep architecture and high-frequency Heart Rate Variability (HF-HRV), as well as cognitive performance after both a well-rested and sleep-deprived night.

Detailed Description

Sleep is physiologically important for memory consolidation, mood and hormonal regulation, and maintaining low levels of systemic inflammation. However, a substantial proportion of people are reported to regularly sleep less than the recommended 7-9 hours a night. Meditation may be a means to mitigate the negative effects of sleep deprivation, as many types of meditations are associated with increasing high-frequency heart rate variability (HF-HRV), which is an index of parasympathetic control of the heart. Greater parasympathetic drive may be associated with physiological buffering of the detrimental effects of 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 continue their usual routine. Subjects will be asked to complete some cognitive tests before and after a night of sleep and a night of sleep deprivation. During the night of sleep, participants will undergo polysomnography recording for sleep architecture and quality. The intervention group will be asked to undergo these same study procedures after 2 months of meditation practice. The control group, which continues their usual routine, will only undergo one visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep, Sleep Deprivation, Cognitive Change

Keywords

sleep, sleep disorder, sleep deprivation, Meditation, Shoonya meditation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nap Practitioners

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Shoonya Meditators

Arm Type

Active Comparator

Arm Description

Arm Title

Control Meditators

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Nap Practitioners

Intervention Description

Regular nappers will be given a 30 minute nap opportunity to nap for as long as they please.

Intervention Type

Behavioral

Intervention Name(s)

Shoonya Meditation

Intervention Description

This is a 15 minute meditation, described as a process of conscious non-doing.

Primary Outcome Measure Information:

Title

Error frequency Change: Go-No Go Task

Description

Time Frame

2 months post learning meditation

Secondary Outcome Measure Information:

Title

Reaction Time Change: Go-No Go

Description

The difference in reaction times on the Go-No Go task. The difference in scores pre- and post-sleep deprivation will compared between the control and intervention groups.

Time Frame

2 months post learning meditation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Shoonya meditation program participants/individuals eligible to participate who are healthy adults of age 18 or older, and reside in the United States. Participants must be able and willing to travel to Boston. Nap Group: Healthy adults of age 18 or older that reside in the United States, nap regularly (at least 3 times a week), and do not meditate regularly. Exclusion Criteria: History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis) History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder) Current use of cognition enhancing medications Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week) History (within the last 5 years) of stroke/aneurysm Recent history (< 3 months) of seizures 60 years of age or older History of Heart Attack and Ejection Fraction less than or equal to 30% Pregnancy Non-English speaking History/Diagnosis of any sleep disorder Consumption of 3 or more cups of coffee a day Previously learned shoonya meditation (for the meditator groups)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Balachundhar Subramaniam, MD, MPH

Phone

617-667-2721

sadhgurucenter_research@bidmc.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sepideh Hariri, PhD

Phone

617-667-2721

sadhgurucenter_research@bidmc.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Balachundhar Subramaniam, MD, MPH

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Centre

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Balachundhar Subramaniam, MD, MPH

Phone

617-667-2721

sadhgurucenter_research@bidmc.harvard.edu

First Name & Middle Initial & Last Name & Degree

Balachundhar Subramaniam, MD, MPH

12. IPD Sharing Statement

Citations:

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29132973

Citation

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Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators

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