A Pilot Feasibility Study to Evaluate the Effect of SKY Breath Meditation on Health and Well-being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Refusal rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Refusal rate
时间窗: 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.
Heart rate variability
时间窗: Continuous monitoring over 8-week intervention
Heart rate variability will be collected using the Garmin vivosmart5 watch
Retention rate
时间窗: 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.
Recruitment rate
时间窗: 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.
Adherence rate
时间窗: 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.
Respiration rate
时间窗: Continuous monitoring over 8-week intervention
Respiration rate will be measured using the Garmin vivosmart5 watch
次要结局
- Brief-COPE(Pre/post 8-week intervention)
- Gene expression changes(Pre/post 8 week intervention, and Day 3 (midpoint))
- Social-Connectedness Scale(Pre/post 8-week intervention)
- Perceived Stress Scale(Pre/post 8-week intervention)
- SF-12v2(Pre/post 8-week intervention)
- Proteomic changes(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)
- Epigenetic (DNA Methylation) changes(Pre/post 8 week intervention, and Day 3 (midpoint))
研究者
Ritu Aneja
Professor and Associate Dean for Research & Innovation
University of Alabama at Birmingham