An interventional study of SKY in Stress, Stress, Psychological and Stress, Physiological, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Basic science
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.
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.
783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.
This study's enrollment of 45 is below the median of 85 across 632 interventional studies indexed under Stress, Psychological.
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Exclusion Criteria:
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 30 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
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.
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.
Also known as: Sudarshan Kriya Yoga, SKY Breath Meditation
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Week to week during 8 weeks
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.
Time frame: 8 weeks during intervention period
Heart rate variability
Heart rate variability will be collected using the Garmin vivosmart5 watch
Time frame: Continuous monitoring over 8-week intervention
Respiration rate
Respiration rate will be measured using the Garmin vivosmart5 watch
Time frame: Continuous monitoring over 8-week intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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. The Social Connectedness Scale Revised \[SCS-R; Cronbach's Alpha=0.94\] will be used to measure social connectedness.
Time frame: Pre/post 8-week intervention
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.
Time frame: Pre/post 8 week intervention, and Day 3 (midpoint)
Gene expression changes
RNA level changes between SKY and control groups will be examined.
Time frame: Pre/post 8 week intervention, and Day 3 (midpoint)
Proteomic changes
Protein level changes between SKY and control groups will be examined.
Time frame: Pre/post 8 week intervention
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.
Time frame: Pre/post 8-week intervention
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.
Time frame: Pre/post 8-week intervention
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
Time frame: Pre/post 8-week intervention
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University of Alabama at Birmingham