NCT03858309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

October 29, 2025

Completed
Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

5 months

First QC Date

February 22, 2019

Results QC Date

November 24, 2020

Last Update Submit

October 15, 2025

Conditions

Keywords

Cerebrospinal FluidCerebrospinal Fluid FlowCerebrospinal Fluid CirculationYogaYogic BreathworkMagnetic Resonance ImagingBreathingSleepRT-PCMRICSF FlowSlow BreathingRespiration

Outcome Measures

Primary Outcomes (1)

  • CSF Flow Velocities

    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).

Secondary Outcomes (4)

  • 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).

Study Arms (2)

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).

Behavioral: Breathing Group 1

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).

Behavioral: Breathing Group 2

Interventions

The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.

Breathing Group 1

The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.

Breathing Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Respiratory AspirationHypoventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory InsufficiencySigns and Symptoms, RespiratorySigns and Symptoms

Limitations and Caveats

* Lack of compatible devices (iPhone or iPad) with the respiration trackers among study participants resulted in a number of participants without respiration trackers. * Technical problems with the respiration trackers resulted in partly no data collection, or no data collection throughout the study for one subject. * Subjects with MRI data motion artifacts and/or subjects unable to follow breathing protocol were excluded from MRI data analysis.

Results Point of Contact

Title
Selda Yildiz, PhD
Organization
Oregon Health & Science University (OHSU)

Study Officials

  • Yildiz

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Associate

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 28, 2019

Study Start

July 10, 2019

Primary Completion

November 25, 2019

Study Completion

July 30, 2020

Last Updated

October 29, 2025

Results First Posted

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations