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CTRI Number  CTRI/2020/02/023098 [Registered on: 03/02/2020] Trial Registered Prospectively
Last Modified On: 15/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Preventive
Other (Specify) [ophthalmology]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The effect of specific breathing techniques on pressure in eye  
Scientific Title of Study   The effect of specific nasal breathing techniques on intra-ocular pressure. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alisha Kulkarni 
Designation  Junior resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College,Manipal, Manipal Academy of Higher Education, Madhavnagar, Manipal- 576104

Udupi
KARNATAKA
576104
India 
Phone  7720082811  
Fax    
Email  alisha.kulkarni2811@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogish S Kamath 
Designation  Professor  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College,Manipal, Manipal Academy of Higher Education, Madhavnagar, Manipal- 576104

Udupi
KARNATAKA
576104
India 
Phone  9845308436  
Fax    
Email  yogish.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Yogish S Kamath 
Designation  Professor  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College,Manipal, Manipal Academy of Higher Education, Madhavnagar, Manipal- 576104

Udupi
KARNATAKA
576104
India 
Phone  9845308436  
Fax    
Email  yogish.kamath@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Kasturba Medical College, Manipal, Manipal academy of Higher Education, Madhavnagar, Manipal 576104 
Type of Sponsor  Private medical college 
 
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 Alisha Kulkarni  Kasturba Medical College Manipal  Room No.25; Department of Ophthalmology, Kasturba medical College, Manipal, Manipal Academy of Higher Education, Madhavnagar, Manipal- 576104
Udupi
KARNATAKA 		 7720082811

alisha.kulkarni2811@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Intra-ocular pressure or Physiology of the eye 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal breathing   Intra-ocular pressure and blood pressure will be checked before and after normal nasal breathing 
Intervention  Specific nasal breathing techniques   Intra-ocular pressure and blood pressure will be checked before and after different nasal breathing techniques that will be performed under observation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects coming to the Ophthalmology OPD, Kasturba Hospital, Manipal, as patients or by standers. 
 
ExclusionCriteria 
Details  Patients with following are excluded- participants with shallow anterior chamber depth, k/c/o angle closure suspect or angle closure glaucoma, participants already on anti-glaucoma medications, participants who have consumed 1 liter or more water in last one hour, patients who are k/c/o or giving h/o gross deviated nasal septum, nasal polyps, any other nasal obstruction, allergic or non-allergic rhinitis, URTI, LRTI, COPD or any other significant respiratory disorder, hypertensive patients on beta-blockers or any other drugs affecting the autonomic nervous system, CVS disorders, ANS disorders like orthostatic hypotension, postural orthostatic tachycardia syndrome.  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in the intra-ocular pressure following specific nasal breathing techniques.  5 mins 
 
Secondary Outcome  
Outcome  TimePoints 
blood pressure variation following specific nasal breathing techniques  5 mins 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="164" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2020 
Date of Study Completion (India) 30/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   It has been studied that, there is high prevalence of Sleep Disordered breathing in patients with Primary Open Angle Glaucoma. Sleep disordered breathing is characterized by persistent snoring, upper airway resistance syndrome, and obstructive sleep apnea syndrome. Glaucoma is the condition of the eyes where in  most cases are due to raised intra-ocular pressure. As both these entities seem to be co-related, this study is to determine if specific nasal breathing techniques affects the intra-ocular pressure. Glaucoma is the most common cause of irreversible blindness worldwide. The only therapeutic approach accepted till now is directed towards lowering the intra-ocular pressure (IOP) either by medical, laser or surgical techniques. In addition to these methods, there is a need for evaluating non-pharmacological and non- surgical methods for lowering the IOP. It has been reported that unilateral breathing affects the autonomic nervous system, which in turn affects the IOP. A similar breathing exercise is practiced by many in our country as “Pranayama”. We intend to study the effects of this form of specific nasal breathing technique on the intra-ocular pressure.  
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