- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513846
Brain Age and Sleep Architecture in Meditators (BRANCH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately one hundred and eight (108) 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 108 participants, the study will aim for 57 meditators and 51 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
- Picture vocabulary test
- List sorting working memory test
- Picture Sequence Memory test
- Oral reading recognition test
Emotion Battery:
- Positive Affect CAT
- General Life Satisfaction CAT
- Emotional Support FF
- Instrumental Support FF
- Friendship FF
- Loneliness FF
- Perceived Stress FF
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria (Meditators):
- Previous experience with learning Shambhavi Mahamudra Kriya
- Age 18 years or older.
- Lives in the United States barring California
Inclusion Criteria (Controls):
- Age 18 years or older
- Lives in the United States barring California
Exclusion Criteria (both groups):
- Non-English Speaking
- Night Shift workers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
The DREEM EEG device will be used to measure brain age.
The SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling.
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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.
|
The DREEM EEG device will be used to measure brain age.
The SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measured for 3 weekday and 3 weekend nights during the data collection period
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022P000597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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