- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858309
Influence of Yogic Breathwork on CSF Circulation (CSF)
Quantifying the Influence of Yogic Breathwork on Cerebrospinal Fluid Circulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research protocol is to determine the influence of an 8-week breathing intervention on cerebrospinal fluid (CSF) circulation among healthy participants using a non-invasive real-time phase-contrast magnetic imaging (RT-PCMRI) technique. This aim will be examined by studying the changes in each participant's pre- and post-intervention CSF flow dynamics using the non-invasive RT-PCMRI technique during two MRI scans (one before and one after the 8-week intervention).
The study protocol consists of 20 healthy participants (two groups; 10 in each group with different breathing practices) undergoing an 8-week intervention, and pre-and post-intervention outcome measures.
The two 8-week interventions will be guided by two separate certified experienced yoga teachers. Both interventions will consist of 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week) using home-aid practice materials. Participants' respiration data will be objectively tracked using a wearable respiration tracker device.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-65 years of age, able to provide their consent to be in the study, available and able to participate in study activities, who can lie in supine, able to walk 15 feet, who have no prior/current mind-body practice inducing breath awareness or training such as yoga, meditation, Ta-Chi, Qi-Gong.
Exclusion Criteria:
- Inability to provide informed consent, MRI contraindications, need for muscle relaxants or anti-anxiety drugs in order to tolerate MRI, history of neurological disorders, head trauma with loss of consciousness, craniospinal disorders, spinal injury, sleep disorders, allergic or respiratory disorders, major or uncontrolled psychiatric illness or major depression, lung and heart problems, any condition requiring the use of medication that acts on the brain like stimulants, sedatives current substance abuse issues, pregnancy or nursing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breathing Group 1
Arm 1 will receive an 8-week intervention that consists of a set of breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week).
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The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.
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Active Comparator: Breathing Group 2
Arm 2 will receive an 8-week intervention that consists of slow breathing practices through 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week).
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The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CSF Flow Velocities
Time Frame: Baseline (pre-intervention) and post-intervention (after 8 weeks).
|
We have collected cerebrospinal fluid (CSF) flow measurements during a set of breathing practices while subjects were inside the MRI scanner. MRI-based CSF flow was quantified at the level of Foramen Magnum. Data processing included the extraction of velocity waveforms of the CSF motion ( i.e, CSF velocity in cm/s) and subsequent analysis of CSF velocities across different breathing conditions. Positive CSF velocities indicate fluid motion in the cranial (upward) direction, whereas negative velocities represent fluid motion in the caudal (downward) direction. For the registry, descriptive statistics of CSF velocities (mean and standard deviation) are reported at pre- and post-intervention for participants completing both MRI visits with analyzable CSF data (Group 1 n=7, Group 2 n=7). No inferential statistical tests or change score analyses are included in the registry submission; all reported results are descriptive only. |
Baseline (pre-intervention) and post-intervention (after 8 weeks).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic and Diastolic Blood Pressure
Time Frame: Baseline (pre-intervention) and post-intervention (after 8 weeks).
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Systolic and diastolic blood pressure were measured participants seated at rest at pre- and post-intervention visits.
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Baseline (pre-intervention) and post-intervention (after 8 weeks).
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Body Mass Index (BMI)
Time Frame: Baseline (pre-intervention) and post-intervention (after 8 weeks).
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BMI was collected at pre- and post-intervention visits, and was calculated as weight in kilograms divided by height in meters squared (kg/m²).
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Baseline (pre-intervention) and post-intervention (after 8 weeks).
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Daily Home Practice Frequency
Time Frame: 8 weeks (daily home practice over the course of 8-week intervention).
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Average breathing practice frequency were measured using a wearable respiration tracker to objectively evaluate home practice throughout the intervention: frequency (days/week).
Preliminary analysis estimated mean frequency (days/week) across participants.
Onsite class sessions were excluded.
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8 weeks (daily home practice over the course of 8-week intervention).
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Daily Home Practice Duration
Time Frame: 8 weeks (daily home practice over the course of 8-week intervention).
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Average breathing practice duration were measured using a wearable respiration tracker to objectively evaluate home practice throughout the intervention: duration (in minute).
Preliminary analysis estimated mean duration (minutes) across participants.
Onsite class sessions were excluded.
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8 weeks (daily home practice over the course of 8-week intervention).
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yildiz, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00019281
- K99AT010158-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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