Biometric Changes During MeditationDigMed2NCT01975415
Digital Medicine in Meditation
An observational study of Biometric Changes During Meditation, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This study will investigate the acute response to meditation during a week-long meditation retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of numerous biometric parameters in selected cohorts of experienced and novice meditators during periods of meditation and specific breathing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biometric Changes During Meditation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Participants in this study will be a subset of 40 individuals from a total of ~200 who self-selected to participate in a week-long "Seduction of Spirit" retreat at The Chopra Center in the La Costa Resort in Carlsbad, CA. The 40 anticipated participants will be made up of 2 cohorts: experienced meditators and novice meditators.
Who may be able to join
- Adult over age 18 who are already registered to participate in the week-long "Seduction of the Soul" retreat.
- Capable of providing informed consent
Who cannot join
- Chronic requirement for daily use of chronotropically active medications including beta-blockers, non-dihydropyridine calcium channel blockers, clonidine or beta-agonist inhalers.
- Implantable pacemaker or cardioverter-defibrillator.
- Known allergy to adhesives.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the acute response to meditation during a week-long meditation retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of numerous biometric parameters in selected cohorts of experienced and novice meditators during periods of meditation and specific breathing techniques. Comparisons between cohorts as well as over time will allow for the identification of meditation and/or breathing-related changes.
Read the detailed description
The biometric responses to meditation and breathing techniques will be compared between novice and experienced meditators, as well as initial versus final biometric responses in all participants stratified by cohort. Investigators hypothesize that novice meditators will experience a measurable change in response to mediation over the week-long retreat, whereas experienced meditators will demonstrate a more robust response than novice meditators on the first day of the retreat with less change over the retreat.
- Conditions
- Biometric Changes During Meditation
- Keywords
- Meditation, Sensors, Digital medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experienced Meditators | Self-identified participants who confirm to having a regular meditation practice for at least 3 months and practiced at least 70 minutes per week. | |
| Novice meditators | Self-identified participant who confirm to either having never seriously tried meditation, or who have not meditated more than once a week for at least 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Non-invasive blood pressure
Measured: Participants will be measured at Day 1 and Day 5 of retreat
ECG
5-lead electrocardiogram
Measured: Participants will be measured at Day 1 and Day 5 of retreat
Respiration rate
Respiration rate
Measured: Participants will be measured at Day 1 and Day 5 of retreat
Heart Rate
Heart rate
Measured: Participants will be measured at Day 1 and Day 5 of retreat
Oxygen saturation (SpO2)
Oxygen saturation
Measured: Participants will be measured at Day 1 and Day 5 of retreat
Skin temperature
Skin temperature
Measured: Participants will be measured at Day 1 and Day 5 of retreat
Heart rate variability
Variability in heart rate across a period of time.
Measured: Participants will be measured at Day 1 and Day 5 of retreat
EEG
14-lead Electroencephalogram
Measured: Participants will be measured at Day 1 and Day 5 of retreat
Stress level
Stress level calculated from heart rate variability
Measured: Participants will be measured at Day 1 and Day 5 of retreat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biometric Changes During MeditationStudies 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Chopra Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975415
- Sponsor's protocol ID
- 13 - 6251
- Acronym
- DigMed2
- Status last verified
- Mar 2014
- First submitted
- 17 Oct 2013
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Medicine in Meditation
- ClinicalTrials.gov ID
- NCT01975415
- Acronym / sponsor ID
- DigMed2 / 13 - 6251
- Conditions
- Biometric Changes During Meditation
- Keywords
- Meditation, Sensors, Digital medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- The Chopra Foundation
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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 study will investigate the acute response to meditation during a week-long meditation retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of numerous biometric parameters in selected cohorts of experienced and novice meditators during periods of meditation and specific breathing techniques. Comparisons between cohorts as well as over time will allow for the identification of meditation and/or breathing-related changes.
Detailed description
The biometric responses to meditation and breathing techniques will be compared between novice and experienced meditators, as well as initial versus final biometric responses in all participants stratified by cohort. Investigators hypothesize that novice meditators will experience a measurable change in response to mediation over the week-long retreat, whereas experienced meditators will demonstrate a more robust response than novice meditators on the first day of the retreat with less change over the retreat.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experienced Meditators | – | –Self-identified participants who confirm to having a regular meditation practice for at least 3 months and practiced at least 70 minutes per week. |
| Novice meditators | – | –Self-identified participant who confirm to either having never seriously tried meditation, or who have not meditated more than once a week for at least 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be a subset of 40 individuals from a total of ~200 who self-selected to participate in a week-long "Seduction of Spirit" retreat at The Chopra Center in the La Costa Resort in Carlsbad, CA. The 40 anticipated participants will be made up of 2 cohorts: experienced meditators and novice meditators.
Key inclusion criteria (2 listed)
- Adult over age 18 who are already registered to participate in the week-long "Seduction of the Soul" retreat.
- Capable of providing informed consent
Key exclusion criteria (3 listed)
- Chronic requirement for daily use of chronotropically active medications including beta-blockers, non-dihydropyridine calcium channel blockers, clonidine or beta-agonist inhalers.
- Implantable pacemaker or cardioverter-defibrillator.
- Known allergy to adhesives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Pressure
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
Non-invasive blood pressure
ECG
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
5-lead electrocardiogram
Respiration rate
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
Respiration rate
Heart Rate
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
Heart rate
Oxygen saturation (SpO2)
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
Oxygen saturation
Skin temperature
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
Skin temperature
Heart rate variability
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
Variability in heart rate across a period of time.
EEG
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
14-lead Electroencephalogram
Stress level
Time frame: Participants will be measured at Day 1 and Day 5 of retreat
Stress level calculated from heart rate variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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 Biometric Changes During Meditation, run by Scripps Translational Science Institute 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Pressure (time frame: Participants will be measured at Day 1 and Day 5 of retreat). The study lists 9 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 13 Mar 2014.