Pranayama Effect on Autonomic Nervous SystemEarly Phase 1PYAMANCT03280589
Pranayama Practice on the Autonomic Nervous System
A Early Phase 1 study testing Sheetali/Sheekari Pranayama, Sitting Quietly and Deep breathing in people with Pranayama Effect on Autonomic Nervous System and Respiration Variability Effect on Nervous System, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The proposed study design will be a randomized, cross-over trial testing different pranayama breathing interventions. Participants (N=40) will perform each of the following five interventions in a randomly assigned order: (1) internal-paced pranayama intervention (Sheetali/Sheetkari for 10 minutes each) (2)… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pranayama Effect on Autonomic Nervous System, Respiration Variability Effect on Nervous System
- What is being tested?
- Sheetali/Sheekari Pranayama, Sitting Quietly and Deep breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 21 Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to roll tongue into tube (queried over the phone and reassessed at visit 1)
- Age ≥ 25 and ≤ 55 (HRV and other ANS parameters change significantly during the aging process)
- BMI ≥ 18.5 and ≤ 34.9 (Body weight effects HRV and ANS parameters)
- Willing and able to give informed consent
- Able to follow protocol and attend visits
- Able to read and write English
- Able to abstain from over-the-counter painkillers like NSAIDs and allergy medications for 24 hours (Zyrtec and Claritin)
Who cannot join
- A regular practice of yoga, meditation, and/or breathing more than once a week (Individuals that have conditioned their ANS through yoga, meditation, and breathing exercise may not respond to the breathing condition like the representative population)
- Formal (Yoga Alliance Sanctioned 200h or 500h course or other comparable ) training in yoga, Mindfulness-Based Stress Reduction, transcendental meditation, Qigong, Tai Chi, and/or other forms of meditation/consciousness expansion practices (Individuals that have conditioned their ANS through yoga, meditation, and breathing exercise may not respond to the breathing condition like the representative population)
- A recent cardiovascular event (e.g. myocardial infarction, stroke ≤ six months prior to screening visit), current coronary artery disease, angina, stage III or IV congestive heart failure, or stated history of coronary bypass surgery or heart stent placement
- Presence of a cardiac pacemaker
- History of cardiovascular disease, including heart arrhythmias and prehypertension (systolic BP > 140 mmHg or diastolic BP >90) or hypotension (systolic BP < 90 mmHg or diastolic BP <60)
- Taking prescription drugs that may interfere with heart, nervous, and respiratory rhythms, beta blockers, pain medications, SSRIs, anti-cholinergics, or anxiety medication
Show all 16Show fewer
- Started or changed the dosage of supplements or medications within the last month
- Open skin rashes and sores that may interfere with placement of sensors
- History of emphysema, chronic bronchitis or bronchiectasis and/or asthma (with FEV1/FVC < 80%) within in the last six months or taking medication to control asthma symptoms
- History of Diabetes type 1 or 2 (> 5 year duration of type 2 diabetes or > 10 years duration of type 1 diabetes (due to the potential for autonomic neuropathy)
- History of or current epilepsy or other seizure disorder(s)
- Current diagnosis of mental illness for which the participant is currently taking prescription medications
- Smoking of tobacco products in a the last 6 months
- Pregnant, nursing, or planning a pregnancy within the next 6 weeks (due to pregnancy-induced changes in HRV
- Presence of any unstable and/or significant medical disorder that would compromise the participant's safety to take part in the trial. Such disorders include any known event that will require beginning new medications and/or prevent adherence to the schedule of study activities over the following 6 weeks
- Chronic hyperventilation (Access by NQ during telephone screen)
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine
Portland, Oregon, 97201
About this study
Official title: The Effect of Respiration Rate During Pranayama Practice on the Autonomic Nervous System
The proposed study design will be a randomized, cross-over trial testing different pranayama breathing interventions. Participants (N=40) will perform each of the following five interventions in a randomly assigned order: (1) internal-paced pranayama intervention (Sheetali/Sheetkari for 10 minutes each) (2) internal-paced deep breathing control (3) external-paced pranayama intervention at a rate of 6 bpm (4) external-paced deep breathing at a rate of 6 bpm (5) sitting quietly with no external instruction.
Read the detailed description
Healthy adult participants (N=40) will be recruited from the general population. Potential participants will contact a study phone line or email expressing their interest, and they will then be contacted in order to schedule a screening telephone interview for an initial assessment of their eligibility. Recruitment will be conducted in the general community using flyers, newspaper advertisements, radio advertisements, and web advertising. NUNM students, faculty, staff and patients will not be specifically targeted for recruitment, although they may see a posted flyer and decide to contact study staff.Screening for potential participants will occur over the phone, using a standardized telephone script and during the first study visit. Prior to all clinical research visits, participants will be called and reminded how to prepare, i.e., avoid extreme physical exercise for one day and refrain from alcohol, caffeinated beverages, and recreational drugs for twelve hours before coming to clinic. The participant will be queried about alcohol, caffeinated beverages, over-the-counter medications, and recreational drugs at the beginning of each visit. If they are not compliant with these instructions, they will be asked to either reschedule their visit until they report compliance or withdraw from the study if compliance is not feasible.
- Height and weight will be measured and recorded and BMI will be calculated (Visit 1 only, if out of range then participant does not meet inclusion criteria and will not be enrolled).
- Heart rate (HR) and blood pressure (BP) will be recorded after the volunteer has been sitting calmly for 5 minutes. The mean of 3 successive recordings with at least 2 minutes between readings will be calculated and recorded as the BP and HR for the visit. (Visit 1 only if out of range then participant does not meet inclusion criteria and will not be enrolled)
- Participants will fill out the pretreatment Mind Body Awareness (visit one and five only) and the Positive Affect Negative Affect Scale (PANAS) questionnaires in order to assess baseline mood.
- Participants will be connected to the ProComp8 infinity Encoder (Thought Technologies) for physiological measurements of EKG (for HR and HRV). For EKG measurement electrodes will be placed on the wrist using adjustable bands. For respiratory measurements thoracic and abdominal sensors will go around the body.
- The order of the following conditions will be randomly assigned (1) self-paced pranayama intervention (Sheetali/Sheetkari consecutively for 10 minutes each) (2) self-paced deep breathing control (3) external-paced pranayama intervention at a rate of 6 bpm (4) external-paced deep breathing at a rate of 6 bpm (5) sitting quietly with no external instruction.
- Before and after measurements will be recorded with the participant's eye open and focused on a on screen image and with eyes closed. This is a common practice in the measurement of EEG due to shifts in Alpha state brain waves when the eyes are closed.
- Each session will follow the pattern below:
- Pre- PANAS questionnaire
- Intro screen (one activity)
- Reviews activities with the participant
- Sensor placement
- Respiration instructions
- EKG instructions
- EEG instructions
- Eyes open before
- Instructions
- Measurement
- Eyes closed before
- Instructions
- Measurement
- Breathing exercise (Activities unique to each condition with video instructions)
- Instructions
- Video instructed breath measurement
- Eyes open after
- Instructions
- Measurement
- Eyes closed after
- Instructions
- Measurement
- Removal of sensors
- Instruction
- Post PANAS questionnaire
- Throughout the session participants will be comfortably seated in a chair and instructed to keep their spine erect. The total duration of each HRV measurement will be about 40 minutes: 10 minutes before the practice, 20-minute video with instructions for each condition (broken up into 5 min sections to allow rest), and 10 minutes after the practice.
- Conditions
- Pranayama Effect on Autonomic Nervous System, Respiration Variability Effect on Nervous System
- Being tested
- Sheetali/Sheekari Pranayama, Sitting Quietly, Deep breathing
- Keywords
- Heart Rate Variability, EEG, Respiration
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sheetali/Sheekari PranayamaOther
Also called Pranayama deep breathing
Most pranayama involves (1) sitting quietly, (2) deep breathing (completely filling and emptying the lungs, at a slow/comfortable pace, with awareness), and (3) a specific mouth, tongue, lip and/or body shape, theorized to enhance the effects of the practice. Practitioners of pranayama modulate the cycles of inspiration and expiration, in a way that is theorized to achieve influence over autonomic functions such as heart rate, heart rate variability (HRV), and baroreflex [6]. For example, the manipulation of the tongue and face during Sheetali and Sheetkari pranayama is intended to stimulate parasympathetic nervous system activity and inhibit the sympathetic nervous system.
Sitting QuietlyOther
Participant breaths in their natural way with out instruction
Deep breathingOther
Participant is required to pay attention to each breath
| Study group | Role | What they receive |
|---|---|---|
| Sitting Quietly | Active comparator | Participants will be instructed to sit comfortably in a chair with both feet flat on the floor, hands on their lap or thighs, rest their eyes (closed or slightly open gazed cast down), release tension in the body, remain still, and allow the chair to support them. Instructions will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. There will be 4 five-minute sessions with a one-minute break in between to allow the participant to rest, adjust posture, and answer any questions. The total duration of this session will be approximately 40 minutes. Receives: Other: Sitting Quietly |
| Deep Breathing Self Paced | Experimental | Participants will be instructed to sit comfortably in a chair with both feet flat on the floor, hands on their lap or thighs, rest their eyes (closed or slightly open gazed cast down), release tension in the body, remain still, and allow the chair to support them. There will be 4 five-minute sessions with a one-minute break in between to allow the participant to rest, adjust posture, and answer any questions. Instruction will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. The total duration of this session will be approximately 40 minutes. Receives: Other: Deep breathing |
| Deep Breathing Externally paced | Experimental | Participants will have an instructional video with auditory queues prompting them to inhale and exhale at 6 bpm (approximately 4 seconds between inhale and exhale). Participants will be instructed to sit comfortably in a chair with both feet flat on the floor, hands on their lap or thighs, rest their eyes (closed or slightly open gazed cast down), release tension in the body, remain still and allow the chair to support them. There will be 4 five-minute sessions with a one-minute break in between to allow the participant to rest, adjust posture, and answer any questions. Instruction will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. The total duration of this session will be approximately 40 minutes. Receives: Other: Deep breathing |
| Sheetali/Sheetkali, self-paced: | Experimental | Participant will follow on-screen instructions for Sheetali/Sheetkari with shaped lips/mouth as indicated (i.e., inhaling through the mouth held specific to each practice and exhaling through nostrils), fully filling and emptying the lungs with each breath. In Sheetali, the tongue is allowed to protrude from the mouth at a comfortable distance and rolled into a tube. Following 10 minutes of Sheetali practice, participants will have a one minute rest followed by Sheetkari. In Sheetkari, the tongue is not rolled into a tube; instead, it is rolled up to touch the upper palate. The teeth are then exposed and the lips are kept apart for inhalation and the mouth is closed, tongue is relaxed, and exhalation occurs through the nose. Study personnel will monitor their posture and breathing rate and pause the recording if additional coaching is necessary. The total duration of this session will be approximately 40 minutes. Receives: Other: Sheetali/Sheekari Pranayama; Other: Deep breathing |
| Sheetali/Sheetkari, externally-paced | Experimental | The participant will follow on screen instruction for Sheetali/Sheetkari with shaped lips/mouth as indicated, fully filling and emptying the lungs with each breath. The tongue is allowed to protrude from the mouth at a comfortable distance and rolled into a tube. Following 10 minutes of Sheetali practice, participants will have a one-minute rest before continuing. In Sheetkari the teeth are exposed and the lips are kept apart for inhalation and the mouth is closed, tongue is relaxed, and exhalation occurs through the nose. Instruction will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. There will be an auditory queue to prompt the participant to breathe in and out. Study personnel will monitor their posture and breathing rate and pause the recording if additional coaching is necessary.The total duration of this session will be approximately 40 minutes. Receives: Other: Sheetali/Sheekari Pranayama; Other: Deep breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability (HRV)
Analysis of EKG spectra before and after the session
Measured: Before and after 20 minutes of breathing excersise
Secondary outcomes (1)
Change in EEG
Analysis of EEG spectra before and after the session
Measured: Before and after 20 minutes of breathing excersise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start15 Aug 2017
- Primary completion15 May 2019
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pranayama Effect on Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Bradley, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280589
- Sponsor's protocol ID
- PYAMA
- Acronym
- PYAMA
- Status last verified
- Mar 2023
- First submitted
- 9 Aug 2017
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharpe E, Lacombe A, Sadowski A, Phipps J, Heer R, Rajurkar S, Hanes D, Jindal RD, Bradley R. Investigating components of pranayama for effects on heart rate variability. J Psychosom Res. 2021 Sep;148:110569. doi: 10.1016/j.jpsychores.2021.110569. Epub 2021 Jul 8.
PubMed 34271528
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiration Rate During Pranayama Practice on the Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT03280589
- Acronym / sponsor ID
- PYAMA / PYAMA
- Conditions
- Pranayama Effect on Autonomic Nervous System, Respiration Variability Effect on Nervous System
- Keywords
- Heart Rate Variability, EEG, Respiration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study design will be a randomized, cross-over trial testing different pranayama breathing interventions. Participants (N=40) will perform each of the following five interventions in a randomly assigned order: (1) internal-paced pranayama intervention (Sheetali/Sheetkari for 10 minutes each) (2) internal-paced deep breathing control (3) external-paced pranayama intervention at a rate of 6 bpm (4) external-paced deep breathing at a rate of 6 bpm (5) sitting quietly with no external instruction.
Detailed description
Healthy adult participants (N=40) will be recruited from the general population. Potential participants will contact a study phone line or email expressing their interest, and they will then be contacted in order to schedule a screening telephone interview for an initial assessment of their eligibility. Recruitment will be conducted in the general community using flyers, newspaper advertisements, radio advertisements, and web advertising. NUNM students, faculty, staff and patients will not be specifically targeted for recruitment, although they may see a posted flyer and decide to contact study staff.Screening for potential participants will occur over the phone, using a standardized telephone script and during the first study visit. Prior to all clinical research visits, participants will be called and reminded how to prepare, i.e., avoid extreme physical exercise for one day and refrain from alcohol, caffeinated beverages, and recreational drugs for twelve hours before coming to clinic. The participant will be queried about alcohol, caffeinated beverages, over-the-counter medications, and recreational drugs at the beginning of each visit. If they are not compliant with these instructions, they will be asked to either reschedule their visit until they report compliance or withdraw from the study if compliance is not feasible.
- Height and weight will be measured and recorded and BMI will be calculated (Visit 1 only, if out of range then participant does not meet inclusion criteria and will not be enrolled).
- Heart rate (HR) and blood pressure (BP) will be recorded after the volunteer has been sitting calmly for 5 minutes. The mean of 3 successive recordings with at least 2 minutes between readings will be calculated and recorded as the BP and HR for the visit. (Visit 1 only if out of range then participant does not meet inclusion criteria and will not be enrolled)
- Participants will fill out the pretreatment Mind Body Awareness (visit one and five only) and the Positive Affect Negative Affect Scale (PANAS) questionnaires in order to assess baseline mood.
- Participants will be connected to the ProComp8 infinity Encoder (Thought Technologies) for physiological measurements of EKG (for HR and HRV). For EKG measurement electrodes will be placed on the wrist using adjustable bands. For respiratory measurements thoracic and abdominal sensors will go around the body.
- The order of the following conditions will be randomly assigned (1) self-paced pranayama intervention (Sheetali/Sheetkari consecutively for 10 minutes each) (2) self-paced deep breathing control (3) external-paced pranayama intervention at a rate of 6 bpm (4) external-paced deep breathing at a rate of 6 bpm (5) sitting quietly with no external instruction.
- Before and after measurements will be recorded with the participant's eye open and focused on a on screen image and with eyes closed. This is a common practice in the measurement of EEG due to shifts in Alpha state brain waves when the eyes are closed.
- Each session will follow the pattern below:
- Pre- PANAS questionnaire
- Intro screen (one activity)
- Reviews activities with the participant
- Sensor placement
- Respiration instructions
- EKG instructions
- EEG instructions
- Eyes open before
- Instructions
- Measurement
- Eyes closed before
- Instructions
- Measurement
- Breathing exercise (Activities unique to each condition with video instructions)
- Instructions
- Video instructed breath measurement
- Eyes open after
- Instructions
- Measurement
- Eyes closed after
- Instructions
- Measurement
- Removal of sensors
- Instruction
- Post PANAS questionnaire
- Throughout the session participants will be comfortably seated in a chair and instructed to keep their spine erect. The total duration of each HRV measurement will be about 40 minutes: 10 minutes before the practice, 20-minute video with instructions for each condition (broken up into 5 min sections to allow rest), and 10 minutes after the practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sitting Quietly | Active comparator | Other: Sitting QuietlyParticipants will be instructed to sit comfortably in a chair with both feet flat on the floor, hands on their lap or thighs, rest their eyes (closed or slightly open gazed cast down), release tension in the body, remain still, and allow the chair to support them. Instructions will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. There will be 4 five-minute sessions with a one-minute break in between to allow the participant to rest, adjust posture, and answer any questions. The total duration of this session will be approximately 40 minutes. |
| Deep Breathing Self Paced | Experimental | Other: Deep breathingParticipants will be instructed to sit comfortably in a chair with both feet flat on the floor, hands on their lap or thighs, rest their eyes (closed or slightly open gazed cast down), release tension in the body, remain still, and allow the chair to support them. There will be 4 five-minute sessions with a one-minute break in between to allow the participant to rest, adjust posture, and answer any questions. Instruction will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. The total duration of this session will be approximately 40 minutes. |
| Deep Breathing Externally paced | Experimental | Other: Deep breathingParticipants will have an instructional video with auditory queues prompting them to inhale and exhale at 6 bpm (approximately 4 seconds between inhale and exhale). Participants will be instructed to sit comfortably in a chair with both feet flat on the floor, hands on their lap or thighs, rest their eyes (closed or slightly open gazed cast down), release tension in the body, remain still and allow the chair to support them. There will be 4 five-minute sessions with a one-minute break in between to allow the participant to rest, adjust posture, and answer any questions. Instruction will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. The total duration of this session will be approximately 40 minutes. |
| Sheetali/Sheetkali, self-paced: | Experimental | Other: Sheetali/Sheekari Pranayama, Other: Deep breathingParticipant will follow on-screen instructions for Sheetali/Sheetkari with shaped lips/mouth as indicated (i.e., inhaling through the mouth held specific to each practice and exhaling through nostrils), fully filling and emptying the lungs with each breath. In Sheetali, the tongue is allowed to protrude from the mouth at a comfortable distance and rolled into a tube. Following 10 minutes of Sheetali practice, participants will have a one minute rest followed by Sheetkari. In Sheetkari, the tongue is not rolled into a tube; instead, it is rolled up to touch the upper palate. The teeth are then exposed and the lips are kept apart for inhalation and the mouth is closed, tongue is relaxed, and exhalation occurs through the nose. Study personnel will monitor their posture and breathing rate and pause the recording if additional coaching is necessary. The total duration of this session will be approximately 40 minutes. |
| Sheetali/Sheetkari, externally-paced | Experimental | Other: Sheetali/Sheekari Pranayama, Other: Deep breathingThe participant will follow on screen instruction for Sheetali/Sheetkari with shaped lips/mouth as indicated, fully filling and emptying the lungs with each breath. The tongue is allowed to protrude from the mouth at a comfortable distance and rolled into a tube. Following 10 minutes of Sheetali practice, participants will have a one-minute rest before continuing. In Sheetkari the teeth are exposed and the lips are kept apart for inhalation and the mouth is closed, tongue is relaxed, and exhalation occurs through the nose. Instruction will be displayed to them with on-screen video segments while the study personnel helps explains the steps, answers questions, and monitors adherence. There will be an auditory queue to prompt the participant to breathe in and out. Study personnel will monitor their posture and breathing rate and pause the recording if additional coaching is necessary.The total duration of this session will be approximately 40 minutes. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able to roll tongue into tube (queried over the phone and reassessed at visit 1)
- Age ≥ 25 and ≤ 55 (HRV and other ANS parameters change significantly during the aging process)
- BMI ≥ 18.5 and ≤ 34.9 (Body weight effects HRV and ANS parameters)
- Willing and able to give informed consent
- Able to follow protocol and attend visits
Key exclusion criteria (16 listed)
- A regular practice of yoga, meditation, and/or breathing more than once a week (Individuals that have conditioned their ANS through yoga, meditation, and breathing exercise may not respond to the breathing condition like the representative population)
- Formal (Yoga Alliance Sanctioned 200h or 500h course or other comparable ) training in yoga, Mindfulness-Based Stress Reduction, transcendental meditation, Qigong, Tai Chi, and/or other forms of meditation/consciousness expansion practices (Individuals that have conditioned their ANS through yoga, meditation, and breathing exercise may not respond to the breathing condition like the representative population)
- A recent cardiovascular event (e.g. myocardial infarction, stroke ≤ six months prior to screening visit), current coronary artery disease, angina, stage III or IV congestive heart failure, or stated history of coronary bypass surgery or heart stent placement
- Presence of a cardiac pacemaker
- History of cardiovascular disease, including heart arrhythmias and prehypertension (systolic BP > 140 mmHg or diastolic BP >90) or hypotension (systolic BP < 90 mmHg or diastolic BP <60)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sheetali/Sheekari PranayamaAlso: Pranayama deep breathingMost pranayama involves (1) sitting quietly, (2) deep breathing (completely filling and emptying the lungs, at a slow/comfortable pace, with awareness), and (3) a specific mouth, tongue, lip and/or body shape, theorized to enhance the effects of the practice. Practitioners of pranayama modulate the cycles of inspiration and expiration, in a way that is theorized to achieve influence over autonomic functions such as heart rate, heart rate variability (HRV), and baroreflex [6]. For example, the manipulation of the tongue and face during Sheetali and Sheetkari pranayama is intended to stimulate parasympathetic nervous system activity and inhibit the sympathetic nervous system. | Other | Sheetali/Sheetkali, self-paced:, Sheetali/Sheetkari, externally-paced |
| Sitting QuietlyParticipant breaths in their natural way with out instruction | Other | Sitting Quietly |
| Deep breathingParticipant is required to pay attention to each breath | Other | Deep Breathing Externally paced, Deep Breathing Self Paced, Sheetali/Sheetkali, self-paced:, Sheetali/Sheetkari, externally-paced |
Primary outcome
Change in Heart Rate Variability (HRV)
Time frame: Before and after 20 minutes of breathing excersise
Analysis of EKG spectra before and after the session
1 secondary outcome
Change in EEG
Time frame: Before and after 20 minutes of breathing excersise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 34271528Sharpe E, Lacombe A, Sadowski A, Phipps J, Heer R, Rajurkar S, Hanes D, Jindal RD, Bradley R. Investigating components of pranayama for effects on heart rate variability. J Psychosom Res. 2021 Sep;148:110569. doi: 10.1016/j.jpsychores.2021.110569. Epub 2021 Jul 8.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sheetali/Sheekari Pranayama, Sitting Quietly and Deep breathing in people with Pranayama Effect on Autonomic Nervous System and Respiration Variability Effect on Nervous System, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (HRV) (time frame: Before and after 20 minutes of breathing excersise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.