Effect of SKY Breath Meditation on Health and Well-being

Study Overview
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Brief Summary
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The goal of this SKY (Sudarshan Kriya Yoga) Breath Meditation study is to investigate changes in DNA methylation patterns in the blood samples collected from individuals before and after engagement in a SKY practice intervention. Secondary outcome measures include behavioral inventories, exploratory transcriptomics, proteomics and physiological measures.

Detailed Description
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The present study will recruit up to 60 participants in the SKY intervention and up to 60 participants in the control group. Recruitment is expected to take up to a year. After providing informed consent, participants will be randomly assigned to the SKY intervention group, or a waitlist control group. Interventions will be performed in-person in Los Angeles and/or San Diego. Prior to interventions, each participant will be asked to fill out behavioral questionnaires containing surveys and standardized cognitive measurements. Participants will be also asked to provide hair and nail samples and blood samples for biological assays. All participants will be scheduled for the questionnaire data collection and specimen collection up to two weeks preceding the start of either intervention. Participants will be asked to wear a Garmin vivoSmart5 smartwatch to collect physiological measures. The SKY intervention will be administered in-person over three sessions over three consecutive days. All participants (SKY and control) will be asked to provide a second blood sample at the end of the third session of the SKY intervention. SKY participants will then engage in a remotely administered follow-up over up to eight weeks' time with the option to attend daily remotely-led breathwork sessions for 45 mins to an hour. Participants will be asked to log daily practice engagement using online surveys through the eight-week follow-up period. Reminders will be provided to the participant intermittently during this time. During the period of eight weeks, the participants will return for 1-hour in-person follow-up SKY sessions once a week. They will be required to attend at least 75% of these weekly sessions. After 8 weeks of follow up, participants will provide a third sample of blood, hair and nail samples, and perform a post-intervention questionnaire. Control participants will also have a similar schedule of data and biological sample collection as the SKY group. Waitlist controls will be provided the opportunity to attend the SKY retreat free of charge at the conclusion of the follow up period. Blood samples will be sent for DNA extraction. DNA samples will only be denoted by study designation for the purposes of this project and will be stripped of all electronic identifiers. Once the DNA is extracted, it will be shipped to Illumina Labs in San Diego for whole genome bisulphite sequencing. As a secondary analysis, samples will go through RNA sequencing and proteomics analysis. Statistical data analysis will be performed to identify disease-associated methylated regions. Hair and nail samples will be deidentified and analyzed to measure changes in cortisol. Physiological measurement changes will be evaluated using data recorded by the Garmin devices.

Official Title
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Effect of SKY Breath Meditation on Epigenetic Changes and Whole Health

Conditions
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Stress, Stress, Psychological, Stress, Physiological, Anxiety, Mental Well Being, Happiness, Resilience

Intervention / Treatment
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* Behavioral: SKY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers over 21 years of age who are willing to meet the standards of the study. Minimum 5th grade equivalent competency in English Agree to complete all follow up sessions per week of SKY Breath practice. Exclusion Criteria: Diagnosis of any major medical condition including, but not limited to: dementia, severe hypertension, cancer, diabetes, rheumatoid arthritis, asthma or respiratory illnesses, history of seizure disorder, Crohn's disease, lupus, colitis, dermatitis, fibromyalgia, HIV, hepatitis B or C. Diagnosis of any psychiatric condition including, but not limited to: severe clinical depression, bipolar disorder, schizophrenia/schizoaffective disorder, suicidal ideation, ADHD Recent history of major psychotic episode within the last 12 months Recent history of consistent substance dependence or abuse either by history or self-report within the last 3 months Major surgery within last 12 weeks On hormone-replacement therapy Taking lithium or lithium-based medication Currently pregnant/breastfeeding or actively trying to become pregnant Underweight or obese Diagnosed with COVID in last 4 weeks Exhibiting symptoms like prolonged cognitive fog or difficulty breathing. Smokes any tobacco products (including cigarettes, vapes, hookah) Heavy alcohol drinker (per CDC definition, 8 or more drinks per week for women, 15 or more drinks per week for men) Concurrently participating in another pilot study/clinical trial of a mind/body intervention Regularly practices (3+ times a week) a formal meditation or breath-based technique

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to either the SKY arm or the control arm, that practices the HEP.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SKY<br>In-person SKY sessions will be 3 hours long on each of 3 consecutive days, and participants must be willing to attend all 3 sessions. Each session comprises a combination of breathwork, emotional resilience training, yoga, and leadership skills. The SKY technique includes a unique set of standardized breathing techniques to rapidly reduce neuroendocrine stress responses and the autonomic imbalance due to sympathetic overdrive. 8 weeks of online and/or in-person sessions will be delivered to participants in the follow-up period after the initial in-person intervention. They will receive intermittent reminders about their daily practice during the 8-week follow-up period. The participants will be asked to engage in daily 35 minute SKY sessions remotely, that is led by an instructor. Each participant will be required to log in the number of times a week they practice. In addition, weekly 60-minute reinforcement sessions will be conducted, in-person. | Behavioral: SKY<br>* The SKY intervention will be administered in-person over three sessions spread over three consecutive days by qualified instructors. Participants will then be followed up over eight weeks' time, where they will be given the option to attend daily 35 minute breathwork sessions, again, guided by experienced instructors. Participants will be required to log whether or not they practiced for each day in the eight-week period. They will also receive intermittent reminders about their daily practice during the 8-week follow-up period.<br>* Other names: SKY Breath Meditation;|
| No Intervention: Control<br>Waitlist control participants will not be provided any intervention. However, they will have the same schedule for data and biological specimen collection as the SKY intervention participants. They will be provided an opportunity to take the SKY retreat free of charge at the end of the follow up period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic (DNA Methylation) changes | DNA Methylation changes in SKY and control groups (pre vs post interventions) will be measured by whole-genome bisulfite sequencing (WGBS). Data analyses will be performed utilizing previously published standard pipelines. | Pre/post 8-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Lower values indicate less stress. | Pre/post 8-week intervention | 
| Brief-COPE | The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Higher scores indicate difficulty with coping. | Pre/post 8-week intervention | 
| Pittsburgh Sleep Quality Assessment | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates poor from good sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Higher scores indicate more sleep disturbances. | Pre/post 8-week intervention | 
| Mini-Mood and Anxiety Symptom Questionnaire | The Mood and Anxiety Symptom Questionnaire (MASQ) is an instrument containing a range of symptoms relevant to depression and anxiety. Items are evaluated for Distress, Anxiety, Depression with higher scores on subcomponents indicate more extreme levels of each metric. | Pre/post 8-week intervention | 
| SF-12v2 | The SF-12v2 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Higher scores indicate better physical and mental health. | Pre/post 8-week intervention | 
| Social-Connectedness Scale | The social connectedness scale assesses the degree to which persons feel connected to others in their social environment. Higher scores indicate more social connectedness. | Pre/post 8-week intervention | 
| Cortisol Levels | Nails and hair samples will be collected and stored using a sample collection kit and washed with water and isopropyl alcohol and dried. Samples will be ground using standard procedures and immunoassayed for cortisol density using enzyme-linked immunosorbent assay. | Pre/post 8-week intervention | 
| Heart rate variability | Heart rate variability will be collected using the Garmin vivosmart5 watch | Pre/post 8-week intervention | 
| O2 max | O2 max will be collected using the Garmin vivosmart5 watch | Pre/post 8-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, breathing, meditation, stress reduction, anxiety, depression, DNA methylation, epigenetic, wearable devices, heart rate variability