A Meditation Intervention on Subconcussive Head Impacts
NCT ID: NCT04225663
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2021-08-02
2022-07-01
Brief Summary
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Detailed Description
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At each study visit, participants will undergo an fMRI-cerebrovascular reactivity (CVR) challenge scanning session as well as an aerobic exercise test on a stationary bike. During the CVR-fMRI scan, the participant will wear a mask that will deliver a blend of oxygen and nitrogen at varying amounts while lying in an MRI scanner. During the aerobic stationary bike assessment, the participant will pedal at a steady state against applied resistance for 10 minutes while wearing an ECG heart rate monitor to observe heart rate. A Biostrap heart rate variability (HRV) wrist monitor will be provided which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. After the conclusion of the sport's season, there will be a follow up scanning session. After the post-season scan, the participant will participate in a breath work meditation intervention over the following two months, twice a week for a 30 minute meditation session.
HIGH SCHOOL ATHLETES:
Participants will be given a Biostrap HRV monitor which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. High school athletes will be randomized into one of two study groups, the control group or the intervention group. The intervention group will receive guided meditation over 2 months (twice a week for 30 mins each session), and will ride a stationary bike at 3 time points. The control group will proceed about their lives normally.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Intervention group
The Intervention group will receive 30-minute sessions of guided meditation. During meditation, they will lie down with their backs and torsos elevated by a mat/soft blocks. They will undergo guided breath work.
Guided Meditation
Participants will meditate in response to the guidance provided by a trained meditation coach in person.
Control group
The Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.
No interventions assigned to this group
Interventions
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Guided Meditation
Participants will meditate in response to the guidance provided by a trained meditation coach in person.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
13 Years
25 Years
ALL
Yes
Sponsors
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Mind and Life Institute, Hadley, Massachusetts
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Christopher T Whitlow, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00062234
Identifier Type: -
Identifier Source: org_study_id
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