Clinical trial NCT03858309: Influence of Yogic Breathwork on CSF Circulation
Official title: Quantifying the Influence of Yogic Breathwork on Cerebrospinal Fluid Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CSF Circulation
Keywords: Cerebrospinal Fluid
Cerebrospinal Fluid Flow
Cerebrospinal Fluid Circulation
Yoga
Yogic Breathwork
Magnetic Resonance Imaging
Breathing
Sleep
RT-PCMRI
CSF Flow
Slow Breathing
Respiration
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-02-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: CSF Flow Velocities
timeFrame: Once before and after the 8-week intervention
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure
timeFrame: Once before and once after the 8-week intervention
measure: Body Mass Index (BMI)
timeFrame: Once before and once after the 8-week intervention
measure: Respiration
timeFrame: 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.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Yildiz
role: PRINCIPAL_INVESTIGATOR
References: