StressNCT05523414
The Effect of SKY Breath Meditation on Health and Well-being
A study testing SKY in people with Stress and Stress, Psychological, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Stress, Psychological, Stress, Physiological
- What is being tested?
- SKY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Study Site: Confidential
San Diego, California, 92129
About this study
Official title: A Pilot Feasibility Study to Evaluate the Effect of SKY Breath Meditation on Health and Well-being
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.
Read the detailed 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.
- Conditions
- Stress, Stress, Psychological, Stress, Physiological, Anxiety, Mental Well Being, Happiness
- Being tested
- SKY
- Keywords
- mindfulness, breathing, meditation, stress reduction, anxiety, depression, DNA methylation, epigenetic, wearable devices, heart rate variability
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Psychological Well-Being, Respiratory Aspiration, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKYBehavioural
Also called Sudarshan Kriya Yoga, SKY Breath Meditation
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.
| Study group | Role | What they receive |
|---|---|---|
| SKY | Experimental | 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. Receives: Behavioral: SKY |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks during intervention period
Heart rate variability
Heart rate variability will be collected using the Garmin vivosmart5 watch
Measured: Continuous monitoring over 8-week intervention
Respiration rate
Respiration rate will be measured using the Garmin vivosmart5 watch
Measured: Continuous monitoring over 8-week intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre/post 8 week intervention, and Day 3 (midpoint)
Gene expression changes
RNA level changes between SKY and control groups will be examined.
Measured: Pre/post 8 week intervention, and Day 3 (midpoint)
Proteomic changes
Protein level changes between SKY and control groups will be examined.
Measured: Pre/post 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Apr 2023
- Primary completion19 Apr 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either the SKY arm or the control arm, that practices the HEP.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Ritu Aneja, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523414
- Sponsor's protocol ID
- IRB-300009383
- Other IDs
- UAB
- Status last verified
- Feb 2026
- First submitted
- 19 Aug 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study to Evaluate the Effect of SKY Breath Meditation on Health and Well-being
- ClinicalTrials.gov ID
- NCT05523414
- Acronym / sponsor ID
- IRB-300009383
- Conditions
- Stress, Stress, Psychological, Stress, Physiological, Anxiety, Mental Well Being, Happiness
- Keywords
- mindfulness, breathing, meditation, stress reduction, anxiety, depression, DNA methylation, epigenetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to either the SKY arm or the control arm, that practices the HEP.
| Arm | Type | Receives |
|---|---|---|
| SKY | Experimental | Behavioral: SKYIn-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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKYAlso: Sudarshan Kriya Yoga, SKY Breath MeditationThe 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. | Behavioural | SKY |
Primary outcome
Recruitment rate
Time frame: Up to 1 year
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.
Refusal rate
Time frame: Up to 1 year
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.
Retention rate
Time frame: Week to week during 8 weeks
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.
Adherence rate
Time frame: 8 weeks during intervention period
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.
Heart rate variability
Time frame: Continuous monitoring over 8-week intervention
Heart rate variability will be collected using the Garmin vivosmart5 watch
Respiration rate
Time frame: Continuous monitoring over 8-week intervention
Respiration rate will be measured using the Garmin vivosmart5 watch
9 secondary outcomes
Perceived Stress Scale
Time frame: Pre/post 8-week intervention
Brief-COPE
Time frame: Pre/post 8-week intervention
Pittsburgh Sleep Quality Assessment
Time frame: Pre/post 8-week intervention
Mini-Mood and Anxiety Symptom Questionnaire
Time frame: Pre/post 8-week intervention
SF-12v2
Time frame: Pre/post 8-week intervention
Social-Connectedness Scale
Time frame: Pre/post 8-week intervention
Epigenetic (DNA Methylation) changes
Time frame: Pre/post 8 week intervention, and Day 3 (midpoint)
Gene expression changes
Time frame: Pre/post 8 week intervention, and Day 3 (midpoint)
Proteomic changes
Time frame: Pre/post 8 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKY in people with Stress and Stress, Psychological, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Up to 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.