Clinical trial NCT05756686: Influence of Yogic Breathwork on Sleep
Official title: Quantifying the Influence of Yogic Breathwork on Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Yogic Breathwork
Digital Health Technology
Yoga
Yogic Breathing
Slow Breathing
Sleep Tracking
Remote Research Studies
Wearable Devices
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-03-06
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep efficiency (SE)
timeFrame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
measure: Wake after sleep onset (WASO)
timeFrame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
Secondary outcomes:
measure: Total sleep time (TST)
timeFrame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
measure: Sleep latency (SL)
timeFrame: 12 weeks (8-week interventions and 2 weeks pre- and post-intervention period).
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: During 2 weeks pre-intervention and 2 weeks post-intervention period
measure: 36-Item Short Form Survey Instrument (SF-36)
timeFrame: During 2 weeks pre-intervention and 2 weeks post-intervention period
measure: Perceived Stress Scale (PSS)
timeFrame: During 2 weeks pre-intervention and 2 weeks post-intervention period
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Selda Yildiz, PhD
role: PRINCIPAL_INVESTIGATOR
References: