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

NCT05523414 | Completed

• 2 other identifiers: IRB-300009383UAB
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

mindfulness; breathing; meditation; stress reduction; anxiety; depression; DNA methylation; epigenetic; wearable devices; heart rate variability

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• Heart rate variability

  Heart rate variability will be collected using the Garmin vivosmart5 watch

  Continuous monitoring over 8-week intervention

• Respiration rate

  Respiration rate will be measured using the Garmin vivosmart5 watch

  Continuous monitoring over 8-week intervention

Secondary Outcomes (9)

• Perceived Stress Scale

  Pre/post 8-week intervention

• Brief-COPE

  Pre/post 8-week intervention

• Pittsburgh Sleep Quality Assessment

  Pre/post 8-week intervention

• Mini-Mood and Anxiety Symptom Questionnaire

  Pre/post 8-week intervention

• SF-12v2

  Pre/post 8-week intervention

Other Outcomes (3)

• Cytokine changes in serum samples

  Pre/post 8-week intervention

• Assessment of changes in mitochondrial DNA damage-associated molecular patterns (mtDNA DAMPs) from blood serum.

  Pre/post 8-week intervention

• Serum biomarkers

  Pre/post 8-week intervention

Study Arms (2)

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.

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.

Interventions

SKY BEHAVIORAL

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

SKY

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

Study Site: Confidential

San Diego, California, 92129, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Psychological Well-Being; Respiratory Aspiration; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only the Principal investigator and study coordinator will have access to identifying information. They will de-identify the data and then send this de-identified data (sequencing data and the other clinical, demographic and behavioral data) into an easily accessible set of files for further analysis by the remaining team members. They will also make sure there are no medical record numbers, intervention type, or other identifying information in this dataset, and that the data is blinded in this respect. The files will be stored behind a secure firewall, so that it can only be accessed with permission by the members of the study group. The data will denote the SKY and control groups as Arm 1 \& Arm 2 without indicating whether they refer to SKY or the control groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean for Research & Innovation

Model Details: Participants are assigned to either the SKY arm or the control arm, that practices the HEP.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 31, 2022
• Study Start: April 1, 2023
• Primary Completion: April 19, 2024
• Study Completion: September 12, 2024
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)