NCT05513846

Brief Summary

This is a single-center, cross-sectional study that will recruit approximately fifty seven (57) meditators and fifty one (51) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

August 22, 2022

Last Update Submit

January 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Brain Age

    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

Study Arms (2)

Meditation

This is the group that will have learned at least Shamhbavi Mahamudra Kriya before they are enrolled in the study.

Device: DREEM EEG DeviceDevice: SleepImage Ring

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 DeviceDevice: SleepImage Ring

Interventions

The DREEM EEG device will be used to measure brain age.

ControlMeditation

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

ControlMeditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Previous experience with learning Shambhavi Mahamudra Kriya
  • Age 18 years or older.
  • Lives in the United States barring California
  • Age 18 years or older
  • Lives in the United States barring California

You may not qualify if:

  • Non-English Speaking
  • Night Shift workers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

November 10, 2022

Primary Completion

July 4, 2025

Study Completion

December 31, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations