Pranayama Practice on the Autonomic Nervous System

NCT03280589 | Completed Early Phase 1 DMC

• 1 other identifier: PYAMA
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Pranayama Effect on Autonomic Nervous System; Respiration Variability Effect on Nervous System

Keywords

Heart Rate Variability; EEG; Respiration

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability (HRV)

  Analysis of EKG spectra before and after the session

  Before and after 20 minutes of breathing excersise

Secondary Outcomes (1)

• Change in EEG

  Before and after 20 minutes of breathing excersise

Other Outcomes (2)

• Change in PANAS Questionnaire

  Before and after 20 minutes of breathing excersise

• Change Mindfullness Questionnaire

  Before and after 20 minutes of breathing excersise

Study Arms (5)

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.

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.

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.

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.

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.

Other: Sheetali/Sheekari Pranayama; Other: Deep breathing

Interventions

Sheetali/Sheekari Pranayama OTHER

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.

Also known as: Pranayama deep breathing

Sheetali/Sheetkali, self-paced:; Sheetali/Sheetkari, externally-paced

Sitting Quietly OTHER

Participant breaths in their natural way with out instruction

Sitting Quietly

Deep breathing OTHER

Participant is required to pay attention to each breath

Deep Breathing Externally paced; Deep Breathing Self Paced; Sheetali/Sheetkali, self-paced:; Sheetali/Sheetkari, externally-paced

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

Location

Related Publications (1)

• 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.

  PMID: 34271528 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: September 12, 2017
• Study Start: August 15, 2017
• Primary Completion: May 15, 2019
• Study Completion: July 21, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)