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CTRI Number  CTRI/2024/07/071352 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effects of Oral and nasal breathing on attention and memory 
Scientific Title of Study   Effects of Oral and nasal breathing on attention and memory using P300 and corsi block 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shirley Telles  
Designation  Research Advisor 
Affiliation  Patanjali Research Foundation (Trust)  
Address  Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  shirleytelles@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shirley Telles  
Designation  Research Advisor 
Affiliation  Patanjali Research Foundation (Trust)  
Address  Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  shirleytelles@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shirley Telles  
Designation  Research Advisor 
Affiliation  Patanjali Research Foundation (Trust)  
Address  Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  shirleytelles@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 
 
Primary Sponsor  
Name  Patanjali Research Foundation Trust 
Address  Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar Uttarakhand, 249405 India  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shirley Telles   Patanjali Research Foundation (Trust)  Clinical Neurophysiology Lab, Department of Yoga Research, 2nd Floor Sadbhawana Building, Patanjali Yogapeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL 		 9897963254

shirleytelles@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Department of Yoga Research, Patanjali Research Foundation (Trust)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  N/A 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Breath awareness  The intervention session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. There for the participates will be assessed before and after 17 minutes of the intervention for P300 event related potentials (at three electrode sites i.e., Fz, Cz and Pz) and corsi block tapping test. Hence the total duration of the intervention will be 17 minutes only. The duration of P300 erp will be recorded for 10 minutes (5 minute before intervention and 5 minute after intervention) using an auditory oddball paradigm. The total duration of Corsi block tests will be 20 minutes with 10 minutes before intervention and 10 minutes after intervention. Corsi block-tapping task (CBTT).The CBTT will be assessed as follws: The CBTT has two parts (i) forward tapping test and (ii) backward tapping test. In the CBTT, nine blue squares will appear on a screen. For each trial, the squares will “light up” as yellow one by one in a varying sequence. After the presentation, the participants will be required to click each of the boxes in the similar order in which they “lit up”. This is the first part of the task, i.e. forward tapping. In the second part of the task, the partcipants will be asked to maintain the reverse order, i.e., backward tapping. The task begins with a two-box sequence to a maximum of nine. The test gets terminated when the participant is not able to remember the sequence for two consecutive trials at any one level 
Intervention  Bumblebee (Bhramari) yoga breathing  The intervention session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. There for the participates will be assessed before and after 17 minutes of the intervention for P300 event related potentials (at three electrode sites i.e., Fz, Cz and Pz) and corsi block tapping test. Hence the total duration of the intervention will be 17 minutes only. The duration of P300 erp will be recorded for 10 minutes (5 minute before intervention and 5 minute after intervention) using an auditory oddball paradigm. The total duration of Corsi block tests will be 20 minutes with 10 minutes before intervention and 10 minutes after intervention. Corsi block-tapping task (CBTT).The CBTT will be assessed as follws: The CBTT has two parts (i) forward tapping test and (ii) backward tapping test. In the CBTT, nine blue squares will appear on a screen. For each trial, the squares will “light up” as yellow one by one in a varying sequence. After the presentation, the participants will be required to click each of the boxes in the similar order in which they “lit up”. This is the first part of the task, i.e. forward tapping. In the second part of the task, the partcipants will be asked to maintain the reverse order, i.e., backward tapping. The task begins with a two-box sequence to a maximum of nine. The test gets terminated when the participant is not able to remember the sequence for two consecutive trials at any one level 
Comparator Agent  Quiet Sitting  The intervention session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. There for the participates will be assessed before and after 17 minutes of the intervention for P300 event related potentials (at three electrode sites i.e., Fz, Cz and Pz) and corsi block tapping test. Hence the total duration of the intervention will be 17 minutes only. The duration of P300 erp will be recorded for 10 minutes (5 minute before intervention and 5 minute after intervention) using an auditory oddball paradigm. The total duration of Corsi block tests will be 20 minutes with 10 minutes before intervention and 10 minutes after intervention. Corsi block-tapping task (CBTT).The CBTT will be assessed as follws: The CBTT has two parts (i) forward tapping test and (ii) backward tapping test. In the CBTT, nine blue squares will appear on a screen. For each trial, the squares will “light up” as yellow one by one in a varying sequence. After the presentation, the participants will be required to click each of the boxes in the similar order in which they “lit up”. This is the first part of the task, i.e. forward tapping. In the second part of the task, the partcipants will be asked to maintain the reverse order, i.e., backward tapping. The task begins with a two-box sequence to a maximum of nine. The test gets terminated when the participant is not able to remember the sequence for two consecutive trials at any one level 
Intervention  Shitkari Pranayam  The intervention session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. There for the participates will be assessed before and after 17 minutes of the intervention for P300 event related potentials (at three electrode sites i.e., Fz, Cz and Pz) and corsi block tapping test. Hence the total duration of the intervention will be 17 minutes only. The duration of P300 erp will be recorded for 10 minutes (5 minute before intervention and 5 minute after intervention) using an auditory oddball paradigm. The total duration of Corsi block tests will be 20 minutes with 10 minutes before intervention and 10 minutes after intervention. Corsi block-tapping task (CBTT).The CBTT will be assessed as follws: The CBTT has two parts (i) forward tapping test and (ii) backward tapping test. In the CBTT, nine blue squares will appear on a screen. For each trial, the squares will “light up” as yellow one by one in a varying sequence. After the presentation, the participants will be required to click each of the boxes in the similar order in which they “lit up”. This is the first part of the task, i.e. forward tapping. In the second part of the task, the partcipants will be asked to maintain the reverse order, i.e., backward tapping. The task begins with a two-box sequence to a maximum of nine. The test gets terminated when the participant is not able to remember the sequence for two consecutive trials at any one level  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  (i) University students
(ii) Age range 20 to 45 years 
 
ExclusionCriteria 
Details  ((i) Persons with cognitive problems based on Mini mental state examination (MMSE) (ii) person with Tinnitus(iii) Person with extra systole based on electrocardiogram (ECG) (iv) Any respiratory problem  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
(i) attention using the P300 event related potentials
(ii) performance in a spatial memory task using the corsi block tapping task 		 Before and after 17 minutes of intervention or control sessions
 
 
Secondary Outcome  
Outcome  TimePoints 
global vigor and affect scale  Before and after intervention or control sessions 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Previously it has been reported that the way we breathe (oral or nasal) influences memory. There are specific yoga practices that allow oral or nasal breathing. With this background the aim of the present study is to determine the immediate effect of oral and nasal yoga breathing practices on attention using the P300 erp and spatial memory using the corsi block tapping test in student volunteers. In the study breath awareness (i.e., being aware towards breathing) and quiet sitting will act as control sessions. 
The duration of each intervention and control session will be for 17 minutes. Assessments will be made before and after 17 minutes of the intervention or control session.    

 
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