We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Yogic Breathing Changes Salivary Components

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02108769
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sundaravadivel Balasubramanian, Medical University of South Carolina

Brief Summary:
Our aim is to analyze two ancient Tamil practices (chanting and breathing exercise) if they are capable of stimulating saliva containing agents that can be beneficial to the nervous system. Our study subjects will perform Tamil chanting and Tamil breathing exercise. Saliva will be collected before, during and after the exercises. We will quantify the specific proteins in these salivary samples. The results will benefit further studies in various patient populations.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Neurodegenerative Diseases Cancer Behavioral: Yogic Breathing Behavioral: Attention Control Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Induction of Salivary Neuromodulators by Chanting and Breathing Exercise
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yogic Breathing
  1. Chanting Om

    1. Sharp deep inhalation through nostrils
    2. Slow exhalation through mouth while chanting Om. At this step the subjects will perform a slow and complete exhalation.

    Repeat for 10 min. During the whole period of chanting, the subjects keep their eyes closed.

  2. Yogic Breathing:

    1. Check which of the two nostrils exhibit free flow of air. For the explanation purpose the nostril with free flow of air is treated as Nostril 1 and the other one as Nostril 2.
    2. Close Nostril 2 and inhale a sharp deep breath through Nostril 1 and then close both the nostrils so no inhaled air escapes. Air should not escape through mouth either. This inhalation step should take about 4 seconds.
    3. Hold breath in this position for about 16 seconds.
    4. Open Nostril 2 and exhale for about 8 seconds. Complete exhalation is required. Abdomen will slowly curve-in as the subject exhales. This is normal and encouraged. No air should leak through the Nostril 1 or mouth.
    5. Go to step a).
Behavioral: Yogic Breathing
  1. Chanting Om

    1. Sharp deep inhalation through nostrils
    2. Slow exhalation through mouth while chanting Om. At this step the subjects will perform a slow and complete exhalation.

    Repeat for 10 min. During the whole period of chanting, the subjects keep their eyes closed.

  2. Yogic Breathing:

    1. Check which of the two nostrils exhibit free flow of air. For the explanation purpose the nostril with free flow of air is treated as Nostril 1 and the other one as Nostril 2.
    2. Close Nostril 2 and inhale a sharp deep breath through Nostril 1 and then close both the nostrils so no inhaled air escapes. Air should not escape through mouth either. This inhalation step should take about 4 seconds.
    3. Hold breath in this position for about 16 seconds.
    4. Open Nostril 2 and exhale for about 8 seconds. Complete exhalation is required. Abdomen will slowly curve-in as the subject exhales. This is normal and encouraged. No air should leak through the Nostril 1 or mouth.
    5. Go to step a).
Other Names:
  • Pranayama
  • Moochu Payirchi

Active Comparator: Attention Control
The participants will read a text of their choice for 20 minutes.
Behavioral: Attention Control
The participants will read a text of their choice for 20 minutes in a one-on-one session with the Yoga Instructor.
Other Name: Control




Primary Outcome Measures :
  1. Nerve growth factor quantification [ Time Frame: Three months from the date of sample collection ]
    Nerve growth factor will be quantified by ELISA and Western blotting.


Secondary Outcome Measures :
  1. Measuring changes in salivary constituents [ Time Frame: 6 months from sample collection ]
    Western blotting, Multiplex ELISA and Lipidomic analysis will be conducted in saliva samples to determine changes in molecular constituents before and after study exercise.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Anyone

Exclusion Criteria:

  • breathing problems (inability to breath through nostrils, chronic bronchitis, emphysema and asthma)
  • speech problems that would prevent chanting
  • inability to listen and follow exercise instructions
  • sinus congestion
  • Sjogren's syndrome
  • chronic dry mouth due to medication or other conditions
  • use of anti-cholinergic medications Informed consent will be obtained from each subject after completely describing the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108769


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Sundaravadivel Balasubramanian, PhD Medical University of South Carolina
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sundaravadivel Balasubramanian, Research Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02108769    
Other Study ID Numbers: Pro00024336
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by Sundaravadivel Balasubramanian, Medical University of South Carolina:
Yoga
Yogic breathing
Saliva
Proteomics
Lipdomics
Nerve growth factor
Thirumanthiram
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Alzheimer Disease
Neurodegenerative Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes