| CTRI Number |
CTRI/2026/01/101415 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Randomized study of vagus nerve stimulation to reduce distress in people with tinnitus |
|
Scientific Title of Study
|
To evaluate the efficacy of Vagus Nerve Stimulation (VNS) in reducing tinnitus-related distress: A Randomised Control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAGRIKA SHARMA |
| Designation |
Ph.D. student |
| Affiliation |
PGIMER |
| Address |
Speech and Hearing Unit, 4th Floor, A Block, Department of Otolaryngology, New OPD, PGIMER
4th Floor, NEW OPD, PGIMER, sector 12, Chandigarh,
160012
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9459366308 |
| Fax |
|
| Email |
sagrika0725@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar Munjal |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Room number 4075, 4th Floor, A block, ENT dept., New OPD, PGIMER, sector 12, Chandigarh,
160012
PGIMER, sector 12, Chandigarh,
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815653262 |
| Fax |
|
| Email |
sanjaymunjal1@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar Munjal |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Room number 4075, 4th Floor, A block, ENT dept., New OPD, PGIMER, sector 12, Chandigarh,
160012
PGIMER, sector 12, Chandigarh,
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815653262 |
| Fax |
|
| Email |
sanjaymunjal1@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh-160012 |
|
|
Primary Sponsor
|
| Name |
Sagrika Sharma |
| Address |
4th Floor, A block, ENT Dept., New OPD, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh- 160012 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Sagrika Sharma |
PGIMER |
Room No 4075, Speech and Hearing Unit, 4th Floor, A Block, ENT Dept., New OPD, PGIMER
Chandigarh
CHANDIGARH |
9459366308
sagrika0725@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Sham vagus nerve stimulation with tinnitus educational counselling |
Participants will receive sham stimulation using the same device without active vagus nerve stimulation. The procedure will mimic active stimulation without delivering therapeutic electrical current. Participants will also receive tinnitus educational counselling. This group will serve as the control arm. |
| Intervention |
Transcutaneous vagus nerve stimulation only with tinnitus educational counselling |
Participants will receive transcutaneous vagus nerve stimulation using a non invasive ear level stimulator targeting the auricular branch of the vagus nerve. Stimulation parameters will be set at a comfortable sensory level below pain threshold as per protocol. Participants will also receive tinnitus educational counselling. No sound therapy will be provided in this group. The intervention will be administered for the duration specified in the study protocol. |
| Intervention |
Transcutaneous vagus nerve stimulation with sound therapy and tinnitus educational counselling |
Participants will receive transcutaneous vagus nerve stimulation delivered using a non invasive ear level stimulator targeting the auricular branch of the vagus nerve. Stimulation will be administered at a comfortable sensory level below pain threshold as per protocol. Participants will also receive sound therapy using customized auditory stimuli along with tinnitus educational counselling. The intervention will be administered for the duration specified in the study protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
subjects within age range of 18-55 years with subjective (can be heard only by oneself) and chronic (greater than 3 months) tinnitus which is continuous in both or one ear. These subjects can be with or without hearing loss, but hearing loss not exceeding more than 50 dBHL in all frequencies i.e. 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz and 8000 Hz. |
|
| ExclusionCriteria |
| Details |
subjects with intermittent (not continuous throughout) or pulsatile tinnitus (vascular in origin) or can be heard by others (objective tinnitus). Subjects having any other otological disorder like Meniere’s disease or otosclerosis, neuropsychiatric, respiratory, or cardiac issues. Subjects with implanted device such as pacemaker or any neurostimulation device |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tinnitus-related distress measured using Tinnitus Functional Index |
Baseline
1-month follow-up
3-month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tinnitus severity measured using Tinnitus Handicap Inventory |
Baseline
1-month follow-up
3-month follow-up |
| Perceived tinnitus loudness measured using visual analogue scale |
Baseline
1-month follow-up
3-month follow-up |
| Sleep quality and stress using validated questionnaire |
Baseline
1-month follow-up
3-month follow-up |
| Electrophysiological tests like P300 and MMN |
Baseline
1-month follow-up
3-month follow-up |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/02/2026 |
| 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="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
|
Tinnitus is a common auditory symptom that can significantly affect the quality of life and psychological well-being of individuals. Current management strategies often provide limited relief, and there is a need to explore neuromodulation-based interventions like vagus nerve stimulation, which has shown promising results for individuals with tinnitus. This study aims to evaluate the efficacy of transcutaneous vagus nerve stimulation in reducing tinnitus-related distress and severity. This is a single-blinded randomized control trial where three interventions will be given with a total sample size of 150 participants diagnosed with chronic subjective tinnitus. Participants will be randomly allocated into three groups in a one-to-one-to-one ratio. Group A will receive transcutaneous vagus nerve stimulation along with sound therapy and tinnitus educational counselling. Group B will receive transcutaneous vagus nerve stimulation with tinnitus educational counselling. Group C will receive sham stimulation with tinnitus educational counselling, where tinnitus educational counselling is the standard care of treatment. Randomization will be performed using block randomization, and allocation will be concealed. The intervention will be administered over a defined treatment period as per the study protocol. Outcome measures will include the tinnitus functional index and tinnitus-related distress assessed using validated questionnaires at baseline and post-intervention at the 3-month follow-up. Along with questionnaires, auditory evoked potentials will be recorded at baseline and post intervention to see any changes that occurred after VNS. The findings of this study are expected to provide evidence regarding the effectiveness of transcutaneous vagus nerve stimulation with and without sound therapy in the management of tinnitus and may help guide future clinical practice. |