Clinical trial NCT05523414: The Effect of SKY Breath Meditation on Health and Well-being
Official title: A Pilot Feasibility Study to Evaluate the Effect of SKY Breath Meditation on Health and Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2022-08-31
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either the SKY arm or the control arm, that practices the HEP.
Primary purpose: BASIC_SCIENCE

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.

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.

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
* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Up to 1 year
measure: Refusal rate
timeFrame: Up to 1 year
measure: Retention rate
timeFrame: Week to week during 8 weeks
measure: Adherence rate
timeFrame: 8 weeks during intervention period
measure: Heart rate variability
timeFrame: Continuous monitoring over 8-week intervention
measure: Respiration rate
timeFrame: Continuous monitoring over 8-week intervention
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Pre/post 8-week intervention
measure: Brief-COPE
timeFrame: Pre/post 8-week intervention
measure: Pittsburgh Sleep Quality Assessment
timeFrame: Pre/post 8-week intervention
measure: Mini-Mood and Anxiety Symptom Questionnaire
timeFrame: Pre/post 8-week intervention
measure: SF-12v2
timeFrame: Pre/post 8-week intervention
measure: Social-Connectedness Scale
timeFrame: Pre/post 8-week intervention
measure: Epigenetic (DNA Methylation) changes
timeFrame: Pre/post 8 week intervention, and Day 3 (midpoint)
measure: Gene expression changes
timeFrame: Pre/post 8 week intervention, and Day 3 (midpoint)
measure: Proteomic changes
timeFrame: Pre/post 8 week intervention
Other outcomes:
measure: Cytokine changes in serum samples
timeFrame: Pre/post 8-week intervention
measure: Assessment of changes in mitochondrial DNA damage-associated molecular patterns (mtDNA DAMPs) from blood serum.
timeFrame: Pre/post 8-week intervention
measure: Serum biomarkers
timeFrame: Pre/post 8-week intervention
Locations:
city: San Diego
country: United States
facility: Study Site: Confidential
state: California
Study officials:
References: