Digital Medicine in Meditation

Biometric Changes During Meditation Clinical Trial

— DigMed2  

Official title:

Digital Medicine in Meditation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975415
• Other study ID #: 13 - 6251
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: March 12, 2014
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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 techniques. Comparisons between cohorts as well as over time will allow for the identification of meditation and/or breathing-related changes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Biometric Changes During Meditation

Locations

Country	Name	City	State
United States	The Chopra Center	Carlsbad	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	The Chopra Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Non-invasive blood pressure	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	ECG	5-lead electrocardiogram	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	Respiration rate	Respiration rate	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	Heart Rate	Heart rate	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	Oxygen saturation (SpO2)	Oxygen saturation	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	Skin temperature	Skin temperature	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	Heart rate variability	Variability in heart rate across a period of time.	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	EEG	14-lead Electroencephalogram	Participants will be measured at Day 1 and Day 5 of retreat	No
Primary	Stress level	Stress level calculated from heart rate variability	Participants will be measured at Day 1 and Day 5 of retreat	No