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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experienced meditators | Experimental | Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year |
|
| Novice meditators | Experimental | No meditation practice in the previous year and < 20 entire lifetime hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With EEGs to Measure Changes in Wave Oscillations | Number of participants who had EEGs to measure qualitative changes in wave oscillations | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Balachundhar Subramaniam | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experienced Meditators | Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year Meditation: . IK is a meditation that can be learned quickly and 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. IK does not incorporate a spiritual or religious focus |
| FG001 | Novice Meditators | No meditation practice in the previous year and < 20 entire lifetime hours Meditation: . IK is a meditation that can be learned quickly and 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. IK does not incorporate a spiritual or religious focus |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experienced Meditators | Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year Meditation: . IK is a meditation that can be learned quickly and 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. IK does not incorporate a spiritual or religious focus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With EEGs to Measure Changes in Wave Oscillations | Number of participants who had EEGs to measure qualitative changes in wave oscillations | 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. Following data cleaning for signal strength & intensity among these 10 participants, only 7 participants (3 Experienced & 4 Novice) had usable data for analysis. | Posted | Number | Participants with Evaluable EEGs | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experienced Meditators | Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year Meditation: . IK is a meditation that can be learned quickly and 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. IK does not incorporate a spiritual or religious focus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Balachundhar Subramaniam | Beth Israel Deaconess Medical Center | 617-634- 2721 | bsubrama@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2020 | May 5, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2019 | May 5, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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, 12 minutes each time.
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Not provided
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|
| Enobio 32- EEG machine | Device | 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 who had evaluable EEGs to measure qualitative changes in wave latency |
| 6 weeks |
| BG001 | Novice Meditators | No meditation practice in the previous year and < 20 entire lifetime hours Meditation: . IK is a meditation that can be learned quickly and 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. IK does not incorporate a spiritual or religious focus |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Novice Meditators | No meditation practice in the previous year and < 20 entire lifetime hours Meditation: . IK is a meditation that can be learned quickly and 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. IK does not incorporate a spiritual or religious focus |
|
|
| Secondary | 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 | 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. Following data cleaning for signal strength & intensity among these 10 participants, only 7 participants (3 Experienced & 4 Novice) had usable data for analysis. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | 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 | 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. Following data cleaning for signal strength & intensity among these 10 participants, only 7 participants (3 Experienced & 4 Novice) had usable data for analysis. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Novice Meditators | No meditation practice in the previous year and < 20 entire lifetime hours Meditation: . IK is a meditation that can be learned quickly and 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. IK does not incorporate a spiritual or religious focus | 0 | 9 | 0 | 9 | 0 | 9 |
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| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |