Pranayama Practice on the Autonomic Nervous System

Completed · Early Phase 1

Conditions studied: Pranayama Effect on Autonomic Nervous System, Respiration Variability Effect on Nervous System

In brief

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.

Key facts

Study ID

NCT03280589

Run by

National University of Natural Medicine

People needed

25

Starts

2017-08-15

Expected to finish

2021-07-21

Last updated by the study team

2023-03-24

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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
• Chronic hyperventilation (Access by NQ during telephone screen)

Where it is running

• National University of Natural Medicine — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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