- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01975415
Digital Medicine in Meditation (DigMed2)
March 12, 2014 updated by: Scripps Translational Science Institute
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Carlsbad, California, United States, 92009
- The Chopra Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Adult over age 18 who are already registered to participate in the week-long "Seduction of the Soul" retreat.
- Capable of providing informed consent
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
|
Non-invasive blood pressure
|
Participants will be measured at Day 1 and Day 5 of retreat
|
ECG
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
|
5-lead electrocardiogram
|
Participants will be measured at Day 1 and Day 5 of retreat
|
Respiration rate
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
|
Respiration rate
|
Participants will be measured at Day 1 and Day 5 of retreat
|
Heart Rate
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
|
Heart rate
|
Participants will be measured at Day 1 and Day 5 of retreat
|
Oxygen saturation (SpO2)
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
|
Oxygen saturation
|
Participants will be measured at Day 1 and Day 5 of retreat
|
Skin temperature
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
|
Skin temperature
|
Participants will be measured at Day 1 and Day 5 of retreat
|
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.
|
Participants will be measured at Day 1 and Day 5 of retreat
|
EEG
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
|
14-lead Electroencephalogram
|
Participants will be measured at Day 1 and Day 5 of retreat
|
Stress level
Time Frame: Participants will be measured at Day 1 and Day 5 of retreat
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Stress level calculated from heart rate variability
|
Participants will be measured at Day 1 and Day 5 of retreat
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
October 17, 2013
First Submitted That Met QC Criteria
October 28, 2013
First Posted (Estimate)
November 3, 2013
Study Record Updates
Last Update Posted (Estimate)
March 13, 2014
Last Update Submitted That Met QC Criteria
March 12, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13 - 6251
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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