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

Target enrollment

13 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-03-28

Participant Flow

Participant milestones

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

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

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=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Age, Continuous	54 years STANDARD_DEVIATION 9.04 • n=99 Participants	34.75 years STANDARD_DEVIATION 18.84 • n=107 Participants	47.58 years STANDARD_DEVIATION 15.45 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 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

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 weeks

Number of participants who had evaluable EEGs to measure qualitative changes in wave amplitude

Outcome measures

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 weeks

Number of participants who had evaluable EEGs to measure qualitative changes in wave latency

Outcome measures

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