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Influence of Yogic Breathwork on CSF Circulation (CSF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858309
Recruitment Status : Active, not recruiting
First Posted : February 28, 2019
Last Update Posted : March 4, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Selda Yildiz, Oregon Health and Science University

Study Description
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Brief Summary:
The purpose of this research study is to determine the influence of yoga breathing practices on cerebrospinal fluid (CSF) circulation, and to find out primarily if a regular practice of 8-week yoga breathing would enhance CSF circulation as well as if the intervention would improve participant's quality of life, quality of sleep, and reduce existing stress. Participants will be randomized into two arms for different breathing practices.

Condition or disease Intervention/treatment Phase
CSF Circulation Behavioral: Breathing Group 1 Behavioral: Breathing Group 2 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Quantifying the Influence of Yogic Breathwork on Cerebrospinal Fluid Circulation
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : November 25, 2019
Estimated Study Completion Date : February 1, 2021
Arms and Interventions
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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).
 Behavioral: Breathing Group 1
The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.
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).
 Behavioral: Breathing Group 2
The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.


Outcome Measures
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Primary Outcome Measures :
  1. CSF Flow Velocities [ Time Frame: Once before and after the 8-week intervention ]
    The changes in pre- and post- intervention CSF flow velocities will be measured using a non-invasive MRI approach.


Secondary Outcome Measures :
  1. Systolic and Diastolic Blood Pressure [ Time Frame: Once before and once after the 8-week intervention ]
    The changes in pre- and post-intervention blood pressure will be measured.

  2. Body Mass Index (BMI) [ Time Frame: Once before and once after the 8-week intervention ]
    The changes in pre- and post-intervention BMI will be measured. The BMI is derived from each participant's height and weight information.

  3. Respiration [ Time Frame: Respiration data will be collected when participants are performing the breathing practices during the weekly on-site sessions (60-minute/week) and daily home practice (20-minute/day) over the course of 8-week intervention. ]
    Respiration phases will be measured using a wearable respiration tracker to objectively track respiration of participants throughout the interventions.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858309


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Yildiz Oregon Health and Science University
More Information
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Responsible Party: Selda Yildiz, Senior Research Associate, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03858309    
Other Study ID Numbers: STUDY00019281
K99AT010158-01 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selda Yildiz, Oregon Health and Science University:
Cerebrospinal Fluid
Cerebrospinal Fluid Flow
Cerebrospinal Fluid Circulation
Yoga
Yogic Breathwork
Magnetic Resonance Imaging
 Breathing
Sleep
RT-PCMRI
CSF Flow
Slow Breathing
Respiration