NCT05756686

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

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 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2024

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 20, 2023

Last Update Submit

March 18, 2025

Conditions

Keywords

SleepYogic BreathworkDigital Health TechnologyYogaYogic BreathingSlow BreathingSleep TrackingRemote Research StudiesWearable Devices

Outcome Measures

Primary Outcomes (2)

  • Sleep efficiency (SE)

    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)

    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 Outcomes (5)

  • Total sleep time (TST)

    12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).

  • Sleep latency (SL)

    12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).

  • Pittsburgh Sleep Quality Index (PSQI)

    During 2 weeks pre-intervention and 2 weeks post-intervention period

  • 36-Item Short Form Survey Instrument (SF-36)

    During 2 weeks pre-intervention and 2 weeks post-intervention period

  • Perceived Stress Scale (PSS)

    During 2 weeks pre-intervention and 2 weeks post-intervention period

Study Arms (2)

Breathing Group 1

EXPERIMENTAL

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

Breathing Group 2

ACTIVE COMPARATOR

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

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:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Links

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Selda Yildiz, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 6, 2023

Study Start

September 20, 2023

Primary Completion

February 7, 2024

Study Completion

August 17, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations