Sleep Clinical Trial
Official title:
Quantifying the Influence of Yogic Breathwork on Sleep
Verified date | January 2024 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 95 |
Est. completion date | August 1, 2024 |
Est. primary completion date | February 1, 2024 |
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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | |
Primary | 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 | Total sleep time (TST) | 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). | |
Secondary | Sleep latency (SL) | 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). | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | 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 | |
Secondary | 36-Item Short Form Survey Instrument (SF-36) | 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 | |
Secondary | Perceived Stress Scale (PSS) | 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 |
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