| CTRI Number |
CTRI/2024/10/075000 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of Yoga in people with ringing in ears (tinnitus) |
|
Scientific Title of Study
|
The Effect of Yoga Intervention in Subjects with Tinnitus on Audiological Parameters |
| 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 Sanjay Munjal |
| Designation |
Professor and Incharge |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room Number 4075, Speech and Hearing Unit, ENT Department, A Block, 4th Floor, New OPD, PGIMER Chandigarh Chandigarh CHANDIGARH 160012 India |
| Phone |
09815653262 |
| Fax |
|
| Email |
sanjaymunjal1@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjay Munjal |
| Designation |
Professor and Incharge |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room Number 4075, Speech and Hearing Unit, ENT Department, A Block, 4th Floor, New OPD, PGIMER Chandigarh Chandigarh CHANDIGARH 160012 India |
| Phone |
09815653262 |
| Fax |
|
| Email |
sanjaymunjal1@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anuradha Sharma |
| Designation |
Lecturer |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room Number 4081, Speech and Hearing Unit, ENT Department, A Block, 4th Floor, New OPD, PGIMER Chandigarh Chandigarh CHANDIGARH 160012 India |
| Phone |
9872987304 |
| Fax |
|
| Email |
anuradha2ks@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Science & Technology, Technology Bhavan, New Mehrauli Road,, New Delhi-110016. |
|
|
Primary Sponsor
|
| Name |
Dr Sanjay Munjal |
| Address |
ENT Department, 4th Floor, A Block, New OPD, Post Graduate Institute of Medical Education and Research, Chandigarh 160012, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Munjal |
Post Graduate Institute of Medical Education and Research |
new OPD, 4th floor, A block, ENT department, Speech and Hearing Unit,room number 4075, Chandigarh Chandigarh CHANDIGARH |
09815653262
sanjaymunjal1@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group with tinnitus (aged matched ) |
patients in the waiting list will not be given any treatment for tinnitus. |
| Intervention |
Yoga |
yoga asanas along with breathing exercises, and meditation sessions will be taken by a professional yoga instructor |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having Tinnitus in the age range of 20-50 years.
2) Subjects with healthy external and middle ear on clinical examination.
3) Subjects having tinnitus for at least more than 4 weeks.
4) Subjects who will give their consent to the request of the investigator for the assessments.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| scores of tinnitus handicap inventory and Tinnitus severity index questionnaire will be compared for all patients wit tinnitus |
BASELINE
3 MONTHS
6 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
audiological parameters
Tinnitus severity index
perceived stress scale |
baseline
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/11/2024 |
| 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="3" Months="1" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
summary: Tinnitus remains one of most devastating auditory handicaps. Tinnitus is any ringing sensation that can be heard by the person himself without any external stimuli being presented. People with Tinnitus often have difficulty sleeping and concentrating at work, and are annoyed and get anxious thus leading to degraded quality of life of these individuals. It has been estimated that as many as 6-20% of the population experiences a form severe enough to interfere with daily activity. Many consider or are driven to suicide. Moreover, it must be emphasized that there is a relation between Tinnitus and the activity of the prefrontal cortex and limbic system. This part of the brain is related to emotions, thus the association with depression, anxiety and other psychological diseases can be made when Tinnitus is severe hence making it the target of most of the investigations.Innumerable treatments for this condition have been utilized with varying degrees of success by clinicians and patients. The goal of effective Tinnitus management is not necessary to mask or remove the patient’s physical perception of Tinnitus associated sounds. According to Duckro et al "treatment of chronic Tinnitus is more accurately described in terms of management rather than cure"(1). A realistic goal of an effective Tinnitus management program is to help patients understand and gain control over their disease, rather than latter having control over them. Ultimately clinicians should strive to help patients progress to the point where Tinnitus is no longer a negative factor in their lives. Available treatments for management of Tinnitus are diverse. More evidence is available for cognitive-behavioural therapies. Further established treatments include counselling, various forms of sound therapies, methods that attempt to increase input to auditory system, such as hearing aids and cochlear implants, pharmacological treatments, neuro-biofeedback, various forms of electrical stimulation of brain structures, inducing electric current in brain with transcranial direct current stimulation or rTMS. However, evidence for effectiveness of these different treatment strategies is scarce. These therapies present different results among the patients due to different etiologies of Tinnitus. Therefore, a comprehensive evaluation of underlying etiology is mandatory prior to commencement of treatment. Yoga is an ancient and holistic system originated from India, which involves physical postures (asana), breathing exercises (Pranayama) and meditation (shavasana and yoganidra). Yoga has been reported to reduce sympathetic hormones, stimulate the limbic 27 system and activate antagonistic neuromuscular systems. There are various studies about the therapeutic effects of Yoga in reducing anxiety, stress, depression, sleeping disorders, insomnia and hypertension. Many studies have concluded that yoga increases the levels of GABA (gamma-amino butyric acid) which is an inhibitory neurotransmitter which inhibits the electrical activity and thus reduces tinnitus, anxiety as well as depression. Pandey et al, 2010 reported positive effects of Bhramari Pranayam which is a form of yoga in which eyelids are closed followed by relaxation posture along with humming on exhalation. It was found that there was positive effect of this yogic form on physical and emotional features of tinnitus. Thus, he concluded that this particular form of yogic form can be given to individuals who have tinnitus. A recent study done by Köksoy et al, 2022 studied the effect of yoga in patients having subjective tinnitus. Here tinnitus scores before and after yoga sessions was calculated. The scores showed significant results indicating less handicap scores, stress and severity. A systemic review done by Gunjawate et al, 2021 on five studies concluded that yoga has positive effects on tinnitus like reduced stress and anxiety and improved quality of life. All of these parameters were based on subjective parameters. However, most of the studies have not given any difference in audiological parameters. Based on this, we aim to investigate to the effect of Yoga intervention in Tinnitus patients by assessing audiological parameters. Tinnitus remains one of most devastating auditory handicaps. Tinnitus is any ringing sensation that can be heard by the person himself without any external stimuli being presented. People with Tinnitus often have difficulty sleeping and concentrating at work, and are annoyed and get anxious thus leading to degraded quality of life of these individuals. It has been estimated that as many as 6-20% of the population experiences a form severe enough to interfere with daily activity. Many consider or are driven to suicide. Moreover, it must be emphasized that there is a relation between Tinnitus and the activity of the prefrontal cortex and limbic system. This part of the brain is related to emotions, thus the association with depression, anxiety and other psychological diseases can be made when Tinnitus is severe hence making it the target of most of the investigations. Innumerable treatments for this condition have been utilized with varying degrees of success by clinicians and patients. The goal of effective Tinnitus management is not necessary to mask or remove the patient’s physical perception of Tinnitus associated sounds. According to Duckro et al "treatment of chronic Tinnitus is more accurately described in terms of management rather than cure"(1). A realistic goal of an effective Tinnitus management program is to help patients understand and gain control over their disease, rather than latter having control over them. Ultimately clinicians should strive to help patients progress to the point where Tinnitus is no longer a negative factor in their lives. Available treatments for management of Tinnitus are diverse. More evidence is available for cognitive-behavioural therapies. Further established treatments include counselling, various forms of sound therapies, methods that attempt to increase input to auditory system, such as hearing aids and cochlear implants, pharmacological treatments, neuro-biofeedback, various forms of electrical stimulation of brain structures, inducing electric current in brain with transcranial direct current stimulation or rTMS. However, evidence for effectiveness of these different treatment strategies is scarce. These therapies present different results among the patients due to different etiologies of Tinnitus. Therefore, a comprehensive evaluation of underlying etiology is mandatory prior to commencement of treatment. Yoga is an ancient and holistic system originated from India, which involves physical postures (asana), breathing exercises (Pranayama) and meditation (Shavasana and yoganidra). Yoga has been reported to reduce sympathetic hormones, stimulate the limbic 27 system and activate antagonistic neuromuscular systems. There are various studies about the therapeutic effects of Yoga in reducing anxiety, stress, depression, sleeping disorders, insomnia and hypertension. Many studies have concluded that yoga increases the levels of GABA (gamma-amino butyric acid) which is an inhibitory neurotransmitter which inhibits the electrical activity and thus reduces tinnitus, anxiety as well as depression. Pandey et al, 2010 reported positive effects of Bhramari Pranayam which is a form of yoga in which eyelids are closed followed by relaxation posture along with humming on exhalation. It was found that there was positive effect of this yogic form on physical and emotional features of tinnitus. Thus, he concluded that this particular form of yogic form can be given to individuals who have tinnitus. A recent study done by Köksoy et al, 2022 studied the effect of yoga in patients having subjective tinnitus. Here tinnitus scores before and after yoga sessions was calculated. The scores showed significant results indicating less handicap scores, stress and severity. A systemic review done by Gunjawate et al, 2021 on five studies concluded that yoga has positive effects on tinnitus like reduced stress and anxiety and improved quality of life. All of these parameters were based on subjective parameters. However, most of the studies have not given any difference in audiological parameters. Based on this, we aim to investigate to the effect of Yoga intervention in Tinnitus patients by assessing audiological parameters |