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Brain Age and Sleep Architecture in Meditators (BRANCH)

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ClinicalTrials.gov Identifier: NCT05513846
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
This is a single-center, cross-sectional study that will recruit approximately fifty (50) meditators and fifty controls. Individuals that have learned at least the Shambhavi Mahamudra Kriya practice and live in Massachusetts will be mailed a DREEM EEG device, and a sleepimage ring. Participants will be asked to wear the two devices while sleeping for three consecutive weekday nights (Sunday night to Thursday night) and two weekend nights (Friday and Saturday nights). While meditating during the day, participants will only wear the DREEM EEG headband. Participants will also undergo neurocognitive tests from the NIH toolbox during one virtual visit via video call. Meditators who join the study will be asked to invite a control subject to the study, matched for age and comorbidities.

Condition or disease Intervention/treatment
Brain Age Device: DREEM EEG Device Device: SleepImage Ring

Detailed Description:

Approximately one hundred (100) individuals will undergo three consecutive weekday nights and two weekend nights of EEG and plethysmography recording using the DREEM headband and SleepImage rings, after answering a demographic questionnaire. Out of these 100 participants, the study will aim for 50 meditators and 50 matched controls. Only meditating participants will be asked to perform the most advanced form of meditation among the following three, which are listed from least advanced to most advanced: Shambhavi Mahamudra Kriya, Shoonya Meditation, Samyama Meditation (Breath watching). Participants will be instructed to wear the DREEM EEG headband during their practice of this meditation during each of the five days.

All participants will also be asked to undergo cognitive assessments from the NIH toolbox during a video call. The assessments from the NIH toolbox will last approximately forty-five minutes to one hour.

EEG: The participants will be mailed the DREEM devices and asked to wear them for three consecutive weekday nights and two weekend nights while sleeping. During the day, for each of these five nights, meditating participants will also be asked to wear the device while they sit still with their eyes closed, without trying to meditate, for 10 minutes. This will function as the baseline waking EEG measurement. Immediately following this, participants will be asked to perform their meditation while wearing the DREEM device for a maximum of 30 minutes.

NIH Toolbox:

This study will use select tests from the NIH Toolbox Cognition Battery and from the NIH Toolbox Emotion Battery. All of the tests together will take approximately 45 minutes to 1 hour to complete.

The selected tests from the batteries are the following:

Cognition Battery

  1. Picture vocabulary test
  2. List sorting working memory test
  3. Picture Sequence Memory test
  4. Oral reading recognition test

Emotion Battery:

  1. Positive Affect CAT
  2. General Life Satisfaction CAT
  3. Emotional Support FF
  4. Instrumental Support FF
  5. Friendship FF
  6. Loneliness FF
  7. Perceived Stress FF
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Brain Age and Sleep Architecture in Meditators
Actual Study Start Date : November 10, 2022
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Meditation
This is the group that will have learned at least Shamhbavi Mahamudra Kriya before they are enrolled in the study.
 Device: DREEM EEG Device
The DREEM EEG device will be used to measure brain age.

Device: SleepImage Ring
The SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling.
Control
This is the group that will not have learned Shambhavi Mahamudra Kriya before they are enrolled in the study. They will be invited to the study by the Meditation group.
 Device: DREEM EEG Device
The DREEM EEG device will be used to measure brain age.

Device: SleepImage Ring
The SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling.


Outcome Measures
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Primary Outcome Measures :
  1. Brain Age [ Time Frame: Measured for 3 weekday and 3 weekend nights during the data collection period ]
    Brain Age will be calculated using an algorithm from the sleeping EEG. A Brain Age index score will be created for each participant based on an aggregate of the five days of sleeping EEG data. The Brain Age Index is the brain age calculated from the algorithm subtracted by the chronological age of the participant.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will not be recruited based on race, ethnicity, or gender. However, it is not clear whether the final study sample will contain a representative spread of the racial and gender makeup.
Criteria

Inclusion Criteria (Meditators):

  1. Previous experience with learning Shambhavi Mahamudra Kriya
  2. Age 18 years or older.
  3. Lives in Massachusetts

Inclusion Criteria (Controls):

  1. Age 18 years or older
  2. Lives in Massachusetts

Exclusion Criteria (both groups):

1. Non-English Speaking

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05513846


Contacts
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Contact: Balachundhar Subramaniam, MD, MPH 617-667-2721 sadhgurucenter_research@bidmc.harvard.edu
Contact: Sepideh Hariri, PhD 617-667-2721 sadhgurucenter_research@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Centre Recruiting
Boston, Massachusetts, United States, 02215
Contact: Balachundhar Subramaniam, MD, MPH    617-667-2721    sadhgurucenter_research@bidmc.harvard.edu   
Principal Investigator: Balachundhar Subramaniam, MD, MPH         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Balachundhar Subramaniam, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05513846    
Other Study ID Numbers: 2022P000597
First Posted: August 24, 2022    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No