Influence of Yogic Breathwork on Sleep

January 9, 2024 updated by: Selda Yildiz, Oregon Health and Science University

Quantifying the Influence of Yogic Breathwork on Sleep

The purpose of this research study is to determine the influence of a regular yogic breathing practice on sleep, and to find out primarily if a regular practice of 8-week yogic breathing would enhance sleep quality as well as if it would improve participant's quality of life, and reduce existing stress. Study participants will be randomized into two arms for different breathing practices.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the effects of two remotely-delivered 8-week breathing interventions on long term sleep patterns.

The study protocol consists of healthy participants (randomized in two breathing groups) undergoing a remotely delivered 8-week intervention and a 12-week sleep tracking period (including 2 week before the intervention, 8 week during the intervention, and 2 week after the intervention). Several sleep metrics will be extracted to characterize long-term sleep patterns and degree of sleep improvement. Participants will also be asked to complete pre- and post-intervention questionnaires.

The two remotely delivered interventions will be guided by two separate certified experienced yoga teachers. Both interventions will include 60-minute weekly group virtual sessions (1day/week) with a 20-minute daily home sessions (in between weekly sessions; 6 days/week) using home-aid practice materials.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Selda Yildiz, PhD
  • Phone Number: (503) 494-7219
  • Email: yildiz@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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
  • who have little to no prior/current regular practice of breath awareness and training
  • compatible devices for physiological data trackers

Exclusion Criteria:

  • Inability to provide informed consent
  • history of neurological disorders, craniospinal disorders, spinal injury
  • diagnosed/treated sleep disorders such as sleep apnea with the use of CPAP
  • allergic or respiratory disorders
  • major or uncontrolled psychiatric illness or trauma 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breathing Group 1
Arm 1 will receive an 8-week remotely delivered intervention that consists of a set of breathing practices through 60-minute weekly virtual group sessions (1day/week) with a 20-minute daily home sessions (in between weekly 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 remotely delivered intervention that consists of slow breathing practices through 60-minute weekly virtual group sessions (1day/week) with a 20-minute daily home sessions (in between weekly 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep efficiency (SE)
Time Frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
SE is a measure ranging from 0 to 100% indicating the percentage time spent asleep relative to total time in bed. SE will be extracted during a 12-week period to then compute changes in SE.
12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Wake after sleep onset (WASO)
Time Frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
WASO is the percentage of time spent awake during the remainder of the sleep period, after the first sleep onset. WASO will be extracted during a 12-week period to then compute changes in WASO.
12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sleep time (TST)
Time Frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
TST is the total time spent asleep. TST will be extracted during a 12-week period to then compute changes in TST.
12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Sleep latency (SL)
Time Frame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
SL is defined by the number of minutes spent awake in bed, prior to first sleep onset. SL will be extracted during a 12-week period to then compute changes in SL.
12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: During 2 weeks pre-intervention and 2 weeks post-intervention period
PSQI is a self-reported questionnaire that is used to assess sleep quality. PSQI scores range from 0 to 21, with higher scores indicating worse outcome.
During 2 weeks pre-intervention and 2 weeks post-intervention period
36-Item Short Form Survey Instrument (SF-36)
Time Frame: During 2 weeks pre-intervention and 2 weeks post-intervention period
SF-36 is a self-reported questionnaire that is used to assess overall health. SF-36 scores range from 0 to 100, with higher scores indicating better health status.
During 2 weeks pre-intervention and 2 weeks post-intervention period
Perceived Stress Scale (PSS)
Time Frame: During 2 weeks pre-intervention and 2 weeks post-intervention period
PSS is a self-reported questionnaire that is used to measure the perception of stress. PSS scores range from 10 to 40, with higher scores indicating worse outcome.
During 2 weeks pre-intervention and 2 weeks post-intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Selda Yildiz, PhD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00025528
  • R00AT010158 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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