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Effect of SKY Breath Meditation on Health and Well-being

Primary Purpose

Stress, Stress, Psychological, Stress, Physiological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SKY
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress focused on measuring mindfulness, breathing, meditation, stress reduction, anxiety, depression, DNA methylation, epigenetic, wearable devices, heart rate variability

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers between the ages of 18-50 who are willing to meet the standards of the study. (After 50, we expect deleterious DNA methylation changes to have accumulated, therefore we are excluding them.)
  • Medical checkup in last 3 years
  • Minimum 5th grade equivalent competency in English
  • Agree to complete 4 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

Sites / Locations

  • Subud HouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SKY

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Heart rate variability
Heart rate variability will be collected using the Garmin vivosmart5 watch
O2 max
O2 max will be collected using the Garmin vivosmart5 watch

Full Information

First Posted
August 19, 2022
Last Updated
July 4, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
M.D. Anderson Cancer Center, Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT05523414
Brief Title
Effect of SKY Breath Meditation on Health and Well-being
Official Title
Effect of SKY Breath Meditation on Epigenetic Changes and Whole Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
M.D. Anderson Cancer Center, Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Stress, Psychological, Stress, Physiological, Anxiety, Mental Well Being, Happiness, Resilience
Keywords
mindfulness, breathing, meditation, stress reduction, anxiety, depression, DNA methylation, epigenetic, wearable devices, heart rate variability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to either the SKY arm or the control arm, that practices the HEP.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SKY
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SKY
Other Intervention Name(s)
Sudarshan Kriya Yoga, SKY Breath Meditation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Epigenetic (DNA Methylation) changes
Description
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.
Time Frame
Pre/post 8-week intervention
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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
Title
Brief-COPE
Description
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
Title
Pittsburgh Sleep Quality Assessment
Description
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
Title
Mini-Mood and Anxiety Symptom Questionnaire
Description
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
Title
SF-12v2
Description
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
Title
Social-Connectedness Scale
Description
The social connectedness scale assesses the degree to which persons feel connected to others in their social environment. Higher scores indicate more social connectedness.
Time Frame
Pre/post 8-week intervention
Title
Cortisol Levels
Description
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.
Time Frame
Pre/post 8-week intervention
Title
Heart rate variability
Description
Heart rate variability will be collected using the Garmin vivosmart5 watch
Time Frame
Pre/post 8-week intervention
Title
O2 max
Description
O2 max will be collected using the Garmin vivosmart5 watch
Time Frame
Pre/post 8-week intervention
Other Pre-specified Outcome Measures:
Title
Proteomic changes in plasma samples
Description
Protein expression profiles will be determined by mass spectrometry and then analyzed by unsupervised hierarchical clustering (HC) and other classification tools to characterize the protein expression profiles.
Time Frame
Pre/post 8-week intervention
Title
Assessment of changes in mitochondrial DNA damage-associated molecular patterns (mtDNA DAMPs) from blood serum.
Description
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
Title
Assessment of changes in gene expression in blood samples
Description
Exploratory transcriptome changes will be measured using next-generation RNA sequencing (RNAseq).
Time Frame
Pre/post 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ritu Aneja, PhD
Phone
205 934 2277
Email
raneja@uab.edu
Facility Information:
Facility Name
Subud House
City
San Diego
State/Province
California
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyam Singh, PhD

12. IPD Sharing Statement

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Effect of SKY Breath Meditation on Health and Well-being

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