Influence of Yogic Breathwork on Sleep

Study Overview
=================
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.

Official Title
-----------------
Quantifying the Influence of Yogic Breathwork on Sleep

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: Breathing Group 1
* Behavioral: Breathing Group 2


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing Group 1<br>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<br>* The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.<br>|
| Active Comparator: Breathing Group 2<br>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<br>* The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Yogic Breathwork, Digital Health Technology, Yoga, Yogic Breathing, Slow Breathing, Sleep Tracking, Remote Research Studies, Wearable Devices