Influence of Yogic Breathwork on CSF Circulation

CSF Circulation Clinical Trial

— CSF  

Official title:

Quantifying the Influence of Yogic Breathwork on Cerebrospinal Fluid Circulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03858309
• Other study ID #: STUDY00019281
• Secondary ID: K99AT010158-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: February 1, 2021
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• CSF Circulation

Intervention

Behavioral:
• Breathing Group 1
The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.
• Breathing Group 2
The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF Flow Velocities	The changes in pre- and post- intervention CSF flow velocities will be measured using a non-invasive MRI approach.	Once before and after the 8-week intervention
Secondary	Systolic and Diastolic Blood Pressure	The changes in pre- and post-intervention blood pressure will be measured.	Once before and once after the 8-week intervention
Secondary	Body Mass Index (BMI)	The changes in pre- and post-intervention BMI will be measured. The BMI is derived from each participant's height and weight information.	Once before and once after the 8-week intervention
Secondary	Respiration	Respiration phases will be measured using a wearable respiration tracker to objectively track respiration of participants throughout the interventions.	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.