The Effect of SKY Breath Meditation on Health and Well-being

Anxiety Clinical Trial

Official title:

A Pilot Feasibility Study to Evaluate the Effect of SKY Breath Meditation on Health and Well-being

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05523414
• Other study ID #: IRB-300009383
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot SKY (Sudarshan Kriya Yoga) Breath Meditation study is to establish feasibility and acceptability of the intervention; and investigate preliminary effectiveness of the intervention at the DNA methylation, RNA and protein levels in blood samples collected from participants before and after the 8 week SKY intervention. Primary outcomes also include preliminary effectiveness at the physiological level using a wearable device used for continuous monitoring. Secondary outcome measures include behavioral inventories.

Description:

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 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 blood samples for biological assays (epigenetics, transcriptomics and proteomics). 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 30 minutes. 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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: April 2025
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

• BMI greater than 35

• 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

Related Conditions & MeSH terms

• Anxiety
• Happiness
• Resilience
• Stress
• Stress, Physiological
• Stress, Psychological

Intervention

Behavioral:
• SKY
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.

Locations

Country	Name	City	State
United States	Study Site: Confidential	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cytokine changes in serum samples	Cytokine changes will be measured using ELISA assay on the blood sample collected and a standard ELISA panel for pro-inflammatory cytokines will be used to detect changes in their levels post intervention.	Pre/post 8-week intervention
Other	Assessment of changes in mitochondrial DNA damage-associated molecular patterns (mtDNA DAMPs) from blood serum.	Cell-free DNA will be eluted to a specified serum volume and used for the mtDNA DAMPs assays.	Pre/post 8-week intervention
Other	Serum biomarkers	Serum samples will be collected using standard procedures from the blood samples and immunoassayed using enzyme-linked immunosorbent assay to detect serum biomarkers	Pre/post 8-week intervention
Primary	Recruitment rate	Descriptive statistics will be used to compute the proportion of screen-eligible participants enrolled by consent. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.	Up to 1 year
Primary	Refusal rate	Descriptive statistics will be used to compute the proportion of screen-eligible individuals who refused to participate. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.	Up to 1 year
Primary	Retention rate	Among the participants who originally attended the 3-day workshop, descriptive statistics will be used to compute proportion of participants that complete all 8 SKY follow-up study visits. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.	Week to week during 8 weeks
Primary	Adherence rate	Descriptive statistics will be used to compute the frequency of home practice completion, weekly, by the intervention participants. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.	8 weeks during intervention period
Primary	Heart rate variability	Heart rate variability will be collected using the Garmin vivosmart5 watch	Continuous monitoring over 8-week intervention
Primary	Respiration rate	Respiration rate will be measured using the Garmin vivosmart5 watch	Continuous monitoring over 8-week intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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. The Social Connectedness Scale Revised [SCS-R; Cronbach's Alpha=0.94] will be used to measure social connectedness.	Pre/post 8-week intervention
Secondary	Epigenetic (DNA Methylation) changes	DNA Methylation changes in SKY and control groups (pre vs post interventions) will be measured by EPIC v2 array and whole-genome bisulfite sequencing (WGBS). Data analyses will be performed utilizing previously published standard pipelines.	Pre/post 8 week intervention, and Day 3 (midpoint)
Secondary	Gene expression changes	RNA level changes between SKY and control groups will be examined.	Pre/post 8 week intervention, and Day 3 (midpoint)
Secondary	Proteomic changes	Protein level changes between SKY and control groups will be examined.	Pre/post 8 week intervention