Brain AgeBRANCHNCT05513846
Brain Age and Sleep Architecture in Meditators
An observational study of Brain Age, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Age
- What is being tested?
- DREEM EEG Device and SleepImage Ring
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Non-English Speaking
- Night Shift workers
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02215
About this study
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.
Read the 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
Retrospective Survey:
Participants will also be asked to complete a retrospective questionnaire assessing meditation practice characteristics and alarm use during their original study participation.
- Conditions
- Brain Age
- Being tested
- DREEM EEG Device, SleepImage Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DREEM EEG DeviceDevice
The DREEM EEG device will be used to measure brain age.
SleepImage RingDevice
The SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling.
| Study group | Role | What they receive |
|---|---|---|
| Meditation | This is the group that will have learned at least Shamhbavi Mahamudra Kriya before they are enrolled in the study. Receives: Device: DREEM EEG Device; Device: 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. Receives: Device: DREEM EEG Device; Device: SleepImage Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Architecture - DREEM EEG
Sleep architecture will be assessed using overnight DREEM EEG recordings. Measures will include including total sleep time, sleep efficiency, and sleep stage duration. Measures will be aggregated across available high-quality recordings for each participant.
Measured: Measured across 5 nights (3 weekday and 2 weekend nights) during the data collection period.
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: Measured for 3 weekday and 2 weekend nights during the data collection period
Sleep Measures - SleepImage Ring
Sleep and cardiopulmonary measures will be assessed using the SleepImage Ring.
Measured: Measured across 5 nights (3 weekday and 2 weekend nights).
Cognitive Function
Cognitive function will be assessed using the NIH Toolbox Cognition Battery: Picture Vocabulary, List Sorting Working Memory, Picture Sequence Memory, and Oral Reading Recognition Tests.
Measured: Assessed once during the study period.
Emotion
Emotional and psychosocial functioning will be assessed using the NIH Toolbox Emotion Battery: Positive Affect, General Life Satisfaction, Emotional Support, Instrumental Support, Friendship, Loneliness, and Perceived Stress measures.
Measured: Assessed once during the study period.
Secondary outcomes (1)
Retrospective Meditation and Sleep Information
Meditators will report meditation type, frequency, and consistency; meditators and controls will report regular alarm use during the study period.
Measured: Assessed once retrospectively following study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start10 Nov 2022
- Primary completion4 Jul 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513846
- Sponsor's protocol ID
- 2022P000597
- Acronym
- BRANCH
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Age and Sleep Architecture in Meditators
- ClinicalTrials.gov ID
- NCT05513846
- Acronym / sponsor ID
- BRANCH / 2022P000597
- Conditions
- Brain Age
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Retrospective Survey:
Participants will also be asked to complete a retrospective questionnaire assessing meditation practice characteristics and alarm use during their original study participation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation | – | Device: DREEM EEG Device, Device: SleepImage RingThis is the group that will have learned at least Shamhbavi Mahamudra Kriya before they are enrolled in the study. |
| Control | – | Device: DREEM EEG Device, Device: SleepImage RingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English Speaking
- Night Shift workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DREEM EEG DeviceThe DREEM EEG device will be used to measure brain age. | Device | Control, Meditation |
| SleepImage RingThe SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling. | Device | Control, Meditation |
Primary outcome
Sleep Architecture - DREEM EEG
Time frame: Measured across 5 nights (3 weekday and 2 weekend nights) during the data collection period.
Sleep architecture will be assessed using overnight DREEM EEG recordings. Measures will include including total sleep time, sleep efficiency, and sleep stage duration. Measures will be aggregated across available high-quality recordings for each participant.
Brain Age
Time frame: Measured for 3 weekday and 2 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.
Sleep Measures - SleepImage Ring
Time frame: Measured across 5 nights (3 weekday and 2 weekend nights).
Sleep and cardiopulmonary measures will be assessed using the SleepImage Ring.
Cognitive Function
Time frame: Assessed once during the study period.
Cognitive function will be assessed using the NIH Toolbox Cognition Battery: Picture Vocabulary, List Sorting Working Memory, Picture Sequence Memory, and Oral Reading Recognition Tests.
Emotion
Time frame: Assessed once during the study period.
Emotional and psychosocial functioning will be assessed using the NIH Toolbox Emotion Battery: Positive Affect, General Life Satisfaction, Emotional Support, Instrumental Support, Friendship, Loneliness, and Perceived Stress measures.
1 secondary outcome
Retrospective Meditation and Sleep Information
Time frame: Assessed once retrospectively following study participation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Age, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Architecture - DREEM EEG (time frame: Measured across 5 nights (3 weekday and 2 weekend nights) during the data collection period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.