An interventional study of Meditation and Enobio 32- EEG machine in Meditation, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Other
Simple meditation and EEG changes
This is a prospective trial enrolling healthy volunteers, including novice meditators and experienced meditators. Subjects will undergo an EEG at baseline and again after 6 weeks. During the 6 weeks, subjects will be asked to meditate twice a day, at least 12 minutes each time.
Novice meditator: No meditation practice in the previous year and \< 20 entire lifetime hours
Expert meditator: Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year
Exclusion Criteria:
Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year
Behavioral: Meditation · Device: Enobio 32- EEG machine
No meditation practice in the previous year and \< 20 entire lifetime hours
Behavioral: Meditation · Device: Enobio 32- EEG machine
Isha Kriya meditation is simple meditation practice which can be easily learned by employing online guided tools. Isha Kriya meditation requires approximately 12 minutes, twice a day of practice. This regimen was chosen because of its simplicity making it an excellent way to introduce meditation to beginners. Isha Kriya does not incorporate a spiritual or religious focus.
This study utilizes the Enobio 32 EEG device made by Neuroelectrics (an FDA-cleared 24-bit EEG data reader which is a wearable wireless device) to analyze EEG changes after subjects have undergone meditation. This study does not evaluate the Enobio device, and the IRB of record approved an Investigational Device Exemption for this study.
Number of Participants With EEGs to Measure Changes in Wave Oscillations
Number of participants who had EEGs to measure qualitative changes in wave oscillations
Time frame: 6 weeks
Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude
Number of participants who had evaluable EEGs to measure qualitative changes in wave amplitude
Time frame: 6 weeks
Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency
Number of participants who had evaluable EEGs to measure qualitative changes in wave latency
Time frame: 6 weeks
| Milestone | Experienced Meditators | Novice Meditators |
|---|---|---|
| Started | 4 | 9 |
| Completed | 3 | 7 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
Number of participants who had EEGs to measure qualitative changes in wave oscillations
| Participants with Evaluable EEGs | Experienced Meditators | Novice Meditators |
|---|---|---|
| Number of Participants With EEGs to Measure Changes in Wave Oscillations | 3 | 4 |
Number of participants who had evaluable EEGs to measure qualitative changes in wave amplitude
| Participants | Experienced Meditators | Novice Meditators |
|---|---|---|
| Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude | 3 | 4 |
Number of participants who had evaluable EEGs to measure qualitative changes in wave latency
| Participants | Experienced Meditators | Novice Meditators |
|---|---|---|
| Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency | 3 | 4 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experienced Meditators | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Novice Meditators | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
Of the 13 participants enrolled in the study 2 participants requested withdrawal and 1 was lost to follow up, resulting in 7 novice meditators and 3 experienced meditators who completed the study.
| Age, Categorical(Participants) | Experienced Meditators | Novice Meditators | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 6 | 9 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Experienced Meditators | Novice Meditators | Total |
|---|---|---|---|
| Mean | 54 ± 9.04 | 34.75 ± 18.84 | 47.58 ± 15.45 |
| Sex: Female, Male(Participants) | Experienced Meditators | Novice Meditators | Total |
|---|---|---|---|
| Female | 0 | 4 | 4 |
| Male | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Experienced Meditators | Novice Meditators | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 7 | 9 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Experienced Meditators | Novice Meditators | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 4 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Beth Israel Deaconess Medical Center