Trial Outcomes & Findings for EEG Changes With Guided Online Meditation (NCT NCT03459690)
NCT ID: NCT03459690
Last Updated: 2024-03-28
Results Overview
Number of participants who had EEGs to measure qualitative changes in wave oscillations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-03-28
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
|
Overall Study
COMPLETED
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
EEG Changes With Guided Online Meditation
Baseline characteristics by cohort
| Measure |
Experienced Meditators
n=3 Participants
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
|
Novice Meditators
n=7 Participants
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
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 9.04 • n=5 Participants
|
34.75 years
STANDARD_DEVIATION 18.84 • n=7 Participants
|
47.58 years
STANDARD_DEVIATION 15.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 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.
Number of participants who had EEGs to measure qualitative changes in wave oscillations
Outcome measures
| Measure |
Experienced Meditators
n=3 Participants
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
|
Novice Meditators
n=7 Participants
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
|
|---|---|---|
|
Number of Participants With EEGs to Measure Changes in Wave Oscillations
|
3 Participants with Evaluable EEGs
|
4 Participants with Evaluable EEGs
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 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.
Number of participants who had evaluable EEGs to measure qualitative changes in wave amplitude
Outcome measures
| Measure |
Experienced Meditators
n=3 Participants
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
|
Novice Meditators
n=7 Participants
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
|
|---|---|---|
|
Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 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.
Number of participants who had evaluable EEGs to measure qualitative changes in wave latency
Outcome measures
| Measure |
Experienced Meditators
n=3 Participants
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
|
Novice Meditators
n=7 Participants
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
|
|---|---|---|
|
Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency
|
3 Participants
|
4 Participants
|
Adverse Events
Experienced Meditators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Novice Meditators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Balachundhar Subramaniam
Beth Israel Deaconess Medical Center
Phone: 617-634- 2721
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place