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Clinical Trials/NCT03858309
NCT03858309CompletedNot Applicable

Quantifying the Influence of Yogic Breathwork on Cerebrospinal Fluid Circulation

Oregon Health and Science University1 site in 1 country26 target enrollmentStarted: July 10, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
CSF Flow Velocities

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Breathing Group 1

Experimental

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).

Intervention: Breathing Group 1 (Behavioral)

Breathing Group 2

Active Comparator

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).

Intervention: Breathing Group 2 (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Systolic and Diastolic Blood Pressure(Baseline (pre-intervention) and post-intervention (after 8 weeks).)
  • Body Mass Index (BMI)(Baseline (pre-intervention) and post-intervention (after 8 weeks).)
  • Daily Home Practice Frequency(8 weeks (daily home practice over the course of 8-week intervention).)
  • Daily Home Practice Duration(8 weeks (daily home practice over the course of 8-week intervention).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Selda Yildiz

Senior Research Associate

Oregon Health and Science University

Study Sites (1)

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