Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice (Yoga)

October 4, 2023 updated by: Carol Worthman, Emory University
This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress, biochemical immunity and longevity markers, and validated psychological measures that relate to mental health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress markers across the sympathetic-adreno-medullar (SAM) axis, biochemical immunity and longevity markers, and validated psychological measures as related to mental health. The study couples emic perspectives from the traditional yoga knowledge base, both textual and practice, with empirical measures from science as an opportunity to bridge these worlds as a first known study of hatha yoga to be tackled by the means and methods of biocultural anthropology. It therefore highlights the importance of context and detail in terms of assessing human behavioral practices, where accuracy in terms of definitions, technique detail, and original purported intentions and outcomes are addressed as relevant when measuring and explaining empirical outcomes under modern research mixed methods.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Lonavla, Maharashtra, India, 410403
        • Kaivalyadhama Yoga Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Novice to breath-based yoga practice
  • Multicultural international participant base
  • Fluent in English comprehension and reading
  • In general good health
  • Have a smartphone or similar device in order to receive surveys on a dedicated app

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Study Group
Participants randomized to the Active Study Group are asked to follow a daily routine of the three protocols of psycho-physical yoga component techniques: Slow Engaged Dynamic Asana (SEDA), Breath Regulated Engaged Meditation (BREM), Sound Heart Engaged Meditation (SHEM). This intervention involves more hours in daily practice to equate to a "high dose" of breath and meditative techniques.
Other: High Dose Yoga
Participants engage in an intensive full yoga practice of hatha breath-based practices and inner meditative techniques along with body-based asana. Intensive level uses breath, management of abdomen, inner focus in all practices. The "high dose" of yoga is an interpretation of the Translational Model of Yoga (TMY) and Yoga Process formula, both developed in this study's cultural research: a systematized psycho-physical yoga method of Hatha Zone (HZ) focus (below-navel, exhale, inner focus), incorporating key components of practice-focus-surrender (PFS) approach and repeat-engage-trust (RET) elements.
Active Comparator: Active Control
Participants randomized to the Active Control study arm are asked to follow a daily routine of low-to mid-intensity body posture practice that is body-based and has minimal breath or meditative elements. This intervention involves fewer hours in daily practice to equate to a "medium dose" of body focused techniques
Other: Medium Dose Yoga
The "medium dose" of yoga is a regular practice of primarily body-posture training with minimal reference to the breath, but with a longer period of time duration in training prior to intervention commencement. Participants have 5 months of pre-training before initiating the intervention.
No Intervention: Passive Control
Participants randomized to the Passive Control study arm do not receive a study intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability (HRV) Between Study Arms
Time Frame: Baseline, up to 6 months
Heart rate variability (HRV) is measured by electrocardiogram.
Baseline, up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability (HRV) Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Heart rate variability (HRV) is measured by electrocardiogram. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Skin Conductance Level (SCL) Between Study Arms
Time Frame: Baseline, up to 6 months
Skin conductance level (SCL) is measured by electrodermal activity (EDA).
Baseline, up to 6 months
Change in Skin conductance level (SCL) Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Skin conductance level (SCL) is measured by electrodermal activity (EDA). Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Skin Conductance Response Between Study Arms
Time Frame: Baseline, up to 6 months
Skin conductance response is measured by electrodermal activity (EDA).
Baseline, up to 6 months
Change in Skin Conductance Response Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Skin conductance response is measured by electrodermal activity (EDA). Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Reactive Oxygen Species (ROS) Levels Between Study Arms
Time Frame: Baseline, up to 6 months
Oxidative stress will be measured by ROS levels.
Baseline, up to 6 months
Change in Reactive Oxygen Species (ROS) Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Oxidative stress will be measured by ROS levels. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Total Antioxidant Status (TAS) Between Study Arms
Time Frame: Baseline, up to 6 months
Change in TAS will be measured by blood sample analysis.
Baseline, up to 6 months
Change in Total Antioxidant Status (TAS) Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Change in TAS will be measured by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Levels of Antioxidant Enzyme Glutathione (GSH) Between Study Arms
Time Frame: Baseline, up to 6 months
Glutathione (GSH) is an antioxidant capable of preventing damage to important cellular components caused by reactive oxygen species such as free radicals, peroxides, lipid peroxides, and heavy metals. Change in levels of GSH will be measured by blood sample analysis.
Baseline, up to 6 months
Change in levels of antioxidant enzyme Glutathione (GSH) Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Glutathione (GSH) is an antioxidant capable of preventing damage to important cellular components caused by reactive oxygen species such as free radicals, peroxides, lipid peroxides, and heavy metals. Change in levels of GSH will be measured by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Levels of Circulating IL-6 Between Study Arms
Time Frame: Baseline, up to 6 months
Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. Levels of circulating IL-6 will be assessed by blood sample analysis.
Baseline, up to 6 months
Change in levels of circulating IL-6 Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. Levels of circulating IL-6 will be assessed by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Levels of Circulating Tumor-Necrosis Factor-alpha (TNF-α) Between Study Arms
Time Frame: Baseline, up to 6 months
Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation. Change in levels of circulating TNF-α will be assessed by blood sample analysis.
Baseline, up to 6 months
Change in levels of circulating TNF-α Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation. Change in levels of Circulating TNF-α will be assessed by blood sample analysis. Participants will be categorized as higher teacher-rated "engaged participation" or lower teacher-rated "engaged participation" and these groups will be compared.
Baseline, up to 6 months
Change in Upper Abdominal Muscle Tension Between Study Arms
Time Frame: Baseline, up to 6 months
Upper abdominal muscular tension levels is assessed as Muscle Tone and Muscle Stiffness, and is measured by the MyotonPlus digital palpation device at a precise site on the upper region of the Rectus Abdominis (RA) muscle.
Baseline, up to 6 months
Change in Upper Abdominal Muscle Tension Between High and Low Participation Level
Time Frame: Baseline, up to 6 months
Upper abdominal muscular tension levels is assessed as Muscle Tone and Muscle Stiffness, and is measured by the MyotonPlus digital palpation device at a precise site on the upper region of the Rectus Abdominis (RA) muscle.
Baseline, up to 6 months
Change in Self-assessment Questions Covering "how do you feel" score
Time Frame: Baseline, up to 6 months
Self-assessment questions covering "how do you feel", with ongoing 3 daily-based questions once a week.
Baseline, up to 6 months
Change in Perceived Stress Reactivity Scale (PSRS) Score
Time Frame: Baseline, up to 6 months
The Perceived Stress Reactivity Scale (PSRS), a 23-item questionnaire with 5 subscales (Prolonged Reactivity, Reactivity to Failure, Reactivity to Social Conflicts, Reactivity to Work Overload, and Reactivity to Social Evaluation) and 1 overall scale. The PSRS overall score ranges from 0 to 30 and higher scores are associated with increased symptoms of depression and sleep disturbances.
Baseline, up to 6 months
Change in Perceived Stress Scale (PSS) Score
Time Frame: Baseline, up to 6 months
The Perceived Stress Scale (PSS) is a 10-item instrument assessing feelings and thoughts related to stress during the past month. Each item is rated on a 5-point scale ranging from never (0) to very often (4). Total scores range from 0 to 40 with higher scores indicating higher perceived stress.
Baseline, up to 6 months
Change in Difficulties in Emotion Regulation Scale (DERS) Score
Time Frame: Baseline, up to 6 months
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item instrument assessing emotion dysregulation and includes six subscales (non-acceptance of emotions, difficulty with goal-directed behavior in the presence of negative emotions, difficulty controlling impulses in the presence of negative emotions, lack of awareness of emotions, limited use of effective emotion regulation strategies, and lack of understanding of emotions). Responses are scaled from 1 (almost never) to 5 (almost always). Total raw scores range from 36 to 180; certain items are reverse scored so that higher scores indicate increased difficulty with emotion regulation.
Baseline, up to 6 months
Change in Depression Anxiety and Stress Scale (DASS) Score
Time Frame: Baseline, up to 6 months
The DASS is a 42-item self-administered questionnaire designed to measure the magnitude of three negative emotional states: depression, anxiety, and stress. The DASS-Depression focuses on reports of low mood, motivation, and self-esteem, DASS-anxiety on physiological arousal, perceived panic, and fear, and DASS-stress on tension and irritability. Individual patient scores on the DASS subscales can be interpreted by converting them to z-scores and comparing to the normative values contained within the DASS manual. A z-score < 0.5 is considered to be within the normal range, a z-score of 0.5 to 1.0 is mild, 1.0 to 2.0 is moderate, 2.0 to 3.0 is considered severe, and z-scores > 3 are considered to be extremely severe depression/anxiety/stress.
Baseline, up to 6 months
Change in Penn State Worry Questionnaire (PSWQ) Score
Time Frame: Baseline, up to 6 months
The Penn State Worry Questionnaire (PSWQ) is a self-administered, 16-item, Likert-type scale designed to measure the trait of worry. Responses to items are rated from 1 to 5 where less worry = 1 and a lot of worry = 5. Total scores range from 16 to 80 and higher scores indicate greater severity of the trait of worry.
Baseline, up to 6 months
Change in Positive and Negative Affect Scale (PANAS) Score
Time Frame: Baseline, up to 6 months
The Positive and Negative Affect Scale (PANAS) consists of 10 positively and 10 negatively valanced word items. Items are rated by the participant for the extent they are feeling this "right now" on a scale of 1- slightly or not at all through 5- extremely. Total scores can range from 10 to 50, with higher scores representing higher levels of positive effect and lower scores having negative effect.
Baseline, up to 6 months
Change in Beck Depression Inventory (BDI-II) Score
Time Frame: Baseline, up to 6 months
The BDI-II is a self-report 21-item scale used to assess the current severity of depression. Each item is rated on a four-point scale (0 to 3) with possible total scores ranging from 0 to 63. Scores provide a measure of the severity of self-reported depression: 0 -9 minimal, 10 -16 mild, 17-29 moderate, and 30 - 63 severe.
Baseline, up to 6 months
Change in Beck Anxiety Inventory (BAI-II) Score
Time Frame: Baseline, up to 6 months
The BAI-II is a 21-item self-report measure of anxiety symptoms, rated on a 4-point Likert scale. Items are rated from 0 = not at all to 3 = severely. Total scores range from 0 to 63 and higher scores indicate greater anxiety.
Baseline, up to 6 months
Change in Profile of Mood States (POMS) Score
Time Frame: Baseline, up to 6 months
The Profile of Mood States (POMS) scale is a 30-item psychological rating scale used to assess transient, distinct mood states. Participants rate the extent to which they feel unhappy, blue, lonely, gloomy, and worthless on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 120 with higher scores reflecting a more negative mood state.
Baseline, up to 6 months
Change in Coping Self-efficacy Scale (CSES) Score
Time Frame: Baseline, up to 6 months
The CSES is a 26-item scale that measures one's perceived ability to cope with life's difficulties. Responses are given on a scale from 0 to 10 where 0 = cannot do at all and 10 = certain can do. Total scores range from 0 to 260 where higher scores indicate greater self-efficacy with coping skills.
Baseline, up to 6 months
Changes in Multidimensional Assessment of Interoceptive Awareness (MAIA) 8-Subscale Scores
Time Frame: Baseline, up to 6 months
The Multidimensional Assessment of Interoceptive Awareness (MAIA) assesses various aspects of interoception with 8 subscales of: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. The subscales include 3 to 7 items and scored by taking the average of the item responses. Responses are given on a 6-point scale where "never" = 0 and "always" = 5. Total scores for each subscale range from 0 to 5 and higher scores indicate greater levels of interoceptive awareness.
Baseline, up to 6 months
Change in Mindful Attention Awareness Scale (MAAS) Score
Time Frame: Baseline, up to 6 months
The Mindful Attention Awareness Scale (MAAS) is a 15-item instrument assessing mindfulness (attention to what is occurring in the present). Responses are given on a 6-point scale where "almost always" = 1 and "almost never" = 6. The total score is the average of responses to the 15 items and ranges from 1 to 6 where higher scores indicate greater mindfulness to the present moment.
Baseline, up to 6 months
Change in Compassion Scale (CS) Score
Time Frame: Baseline, up to 6 months
The Compassion Scale (CS) is a 16-item instrument assessing compassion for others. Responses are given on a 5-point scale where "almost never" = 1 and "almost always" = 5. The total score is the average of responses to the 16 items and ranges from 1 to 5 where higher scores indicate greater compassion towards others.
Baseline, up to 6 months
Change in Self-Compassion Scale - Short Form (SCS-SF) Score
Time Frame: Baseline, up to 6 months
The Self-Compassion Scale - Short Form (SCS-SF) is a 12-item instrument assessing self-compassion. Responses are given on a 5-point scale where "almost never" = 1 and "almost always" = 5. The total score is the average of responses to the 12 items and ranges from 1 to 5 where higher scores indicate greater self-compassion.
Baseline, up to 6 months
Change in Five Facet Mindfulness Questionnaire (FFMQ) Score
Time Frame: Baseline, up to 6 months
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item instrument with five subscales of: Observing, Describing, Acting with Awareness, Nonjudging, and Nonreactivity. Responses are given on a 5-point scale where "never or very rarely true" = 1 and "very often or always true" = 5. Scores can be obtained for each subscale and for a total score by averaging item responses. Total scores range from 1 to 5 where higher scores indicate greater mindfulness.
Baseline, up to 6 months
Change in Heartland Forgiveness Scale Score
Time Frame: Baseline, up to 6 months
The Heartland Forgiveness Scale is an 18-item instrument assessing dispositional forgiveness, with 3 subscales of: Forgiveness of Self, Forgiveness of Others, and Forgiveness of Situations. Responses are given on a 7-point scale where "almost always false of me" = 1 and "almost always true of me" = 7. Total scores for each subscale range from 6 to 42, and the overall total score ranges from 18 to 126. Higher scores indicate greater dispositional forgiveness.
Baseline, up to 6 months
Change in Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) Score
Time Frame: Baseline, up to 6 months
The Cognitive and Affective Mindfulness Scale- Revised (CAMS-R) instrument assessing mindfulness with 12 items. Responses are given on a 4-point scale where "rarely/not at all" = 1 and "almost always" = 5. The total score ranges from 12 to 48 and higher scores indicate greater mindfulness.
Baseline, up to 6 months
Change in Gratitude Questionnaire - Six Item Form (GQ-6) Score
Time Frame: Baseline, up to 6 months
The Gratitude Questionnaire - Six Item Form (GQ-6) instrument measures the experience of gratitude in daily life with 6 items. Responses are given on a 7-point scale where "strongly disagree" = 1 and "strongly agree" = 7. The total score is the average of responses to the 6 items and ranges from 1 to 7 where higher scores indicate greater gratitude.
Baseline, up to 6 months
Change in Spiritual Meaning Scale (SMS) Score
Time Frame: Baseline, up to 6 months
The Spiritual Meaning Scale (SMS) measures an individuals belief that life has a purpose, will, or way. The 14 items are rated on a 5-point Likert scale where "I totally disagree" = 1 and "I totally agree" = 5. Total scores range from 14 to 70 where higher scores indicate greater feelings of spiritual meaning.
Baseline, up to 6 months
Change in Telomere Length (TL)
Time Frame: Baseline, up to 6 months
Telomeres are caps at the ends of chromosomes that, based on primary research, are shown to shorten each time a cell divides. Telomere length (TL) is used as is a marker of cellular aging as shorter telomeres indicate limited cellular life, an indicator of senescence, used overall to comment on longevity of those being measured. Population studies use telomere length (TL) in studies of population health and lifespan. Telomere length (TL) will be measured by blood sample analysis.
Baseline, up to 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Brain-derived Neurotrophic Factor (BDNF) Level in Blood Serum Between Study Arms
Time Frame: Baseline, up to 6 months
Brain-derived neurotrophic factor is a member of the neurotrophin family of growth factors, will be measured by blood sample analysis.
Baseline, up to 6 months
Change in Growth Hormone Level in Blood Serum Between Study Arms
Time Frame: Baseline, up to 6 months
Change in Growth Hormone level will be measured by blood sample analysis.
Baseline, up to 6 months
Change in Oxytocin Level in Blood Serum Between Study Arms
Time Frame: Baseline, up to 6 months
Change in Oxytocin level will be measured by blood sample analysis.
Baseline, up to 6 months
Change in Ghrelin Level in Blood Serum Between Study Arms
Time Frame: Baseline, up to 6 months
Change in Ghrelin level will be measured by blood sample analysis.
Baseline, up to 6 months
Change in Leptin Level in Blood Serum Between Study Arms
Time Frame: Baseline, up to 6 months
Change in Leptin level will be measured by blood sample analysis.
Baseline, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Dallaghan, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00107267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be made available for sharing with other researchers following deidentification.

IPD Sharing Time Frame

Data will be made available for sharing beginning immediately and ending 3 years after publication of the results from this study.

IPD Sharing Access Criteria

Data will be available for sharing with researchers who provide a methodologically sound proposal, for the purposes of achieving the aims of the approved proposal. Proposals should be directed to paul.dallaghan@cuanschutz.edu. To gain access, requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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