| CTRI Number |
CTRI/2024/01/061746 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| 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
|
The effect of different sounds and external electrical pulses on ringing of ears. |
Scientific Title of Study
Modification(s)
|
A study to evaluate the efficacy of vagus nerve stimulation and acoustic stimuli coupling in reducing tinnitus-related distress for chronic subjective tinnitus: a randomised controlled trial (RCT). |
| Trial Acronym |
AVNST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshu Dudeja |
| Designation |
M.Sc. (Audiology) Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Room Number - 441, Speech and Hearing Unit, Dept. of Otorhinolaryngology - Head and Neck Surgery, New OPD, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9711768938 |
| Fax |
|
| Email |
himanshu.dudeja14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himanshu Dudeja |
| Designation |
M.Sc. (Audiology) Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Room Number - 441, Speech and Hearing Unit, Dept. of Otorhinolaryngology - Head and Neck Surgery, New OPD, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9711768938 |
| Fax |
|
| Email |
himanshu.dudeja14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Munjal |
| Designation |
Professor & Incharge, Speech & Hearing Unit, Dept. of Otorhinolaryngology - Head and Neck Surgery |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Room Number - 441, Speech and Hearing Unit, Dept. of Otorhinolaryngology - Head and Neck Surgery, New OPD, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
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), Chandigarh |
|
|
Primary Sponsor
|
| Name |
Himanshu Dudeja |
| Address |
Room Number - 441, Speech and Hearing Unit, Dept. of Otorhinolaryngology - Head and Neck Surgery, New OPD, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanjay Munjal |
Room Number - 441, Speech and Hearing Unit, Dept. of Otorhinolaryngology - Head and Neck Surgery, New OPD, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
|
|
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 (PGIMER), Chandigarh |
Room Number - 441, Speech and Hearing Unit, Dept. of Otorhinolaryngology - Head and Neck Surgery, New OPD, Madhya Marg, Sector 12,Chandigarh, 160012
Chandigarh
CHANDIGARH |
9815653262
sanjaymunjal@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H931||Tinnitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tinnitus Educational Counselling (Active Control) |
Information about the nature of tinnitus, its potential causes, the various treatment options available, the psychological and emotional aspects of living with tinnitus, the coping mechanisms to reduce the impact of tinnitus on activities of daily living and quality of life provided in a single 45 mins session |
| Intervention |
VNS + matched noise |
Non-invasive transcutaneous auricular vagus nerve stimulation provided using Neurostim device (NS2, Medicaid Systems, Punjab, India) at Cymba Concha of left ear at max comfortable level along with a 1-octave band of white noise focused on the tinnitus frequency presented at 5dB SL (re: tinnitus frequency threshold) using custom-made MATLAB (R2023a, The MathWorks, Inc., Massachusetts, USA) code routed to an audiometer (MAICO Diagnostics, MA-42, Pf¨affingen , Germany) via insert earphones (3M E-A-RTONE, 3A, ADCO Hearing Products, Australia) for 30 mins implemented over 3
weeks in a 3-2-1 sessions/week sequence |
| Intervention |
VNS + notched noise |
Non-invasive transcutaneous auricular vagus nerve stimulation provided using Neurostim device (NS2, Medicaid Systems, Punjab, India) at Cymba Concha of left ear at max comfortable level along with a white noise with a 1-octave exclusion focused on the tinnitus frequency presented at 5dB SL (re: tinnitus frequency threshold) using custom-made MATLAB (R2023a, The MathWorks, Inc., Massachusetts, USA) code routed to an audiometer (MAICO Diagnostics, MA-42, Pf¨affingen , Germany) via insert earphones (3M E-A-RTONE, 3A, ADCO Hearing Products, Australia) for 30 mins implemented over 3 weeks in a 3-2-1 sessions/week sequence |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Medically stable male and female adults with chronic, subjective, tonal, continuous Unilateral or bilateral tinnitus
Chronic tinnitus defined as tinnitus onset for more than 3 months |
|
| ExclusionCriteria |
| Details |
Acute, intermittent, noise-like, objective tinnitus
Undergoing any tinnitus treatment in last month
Associated otological, neuropsychiatric, respiratory, cardiac, dermatological problems
Pregnant or breastfeeding
Functioning embedded device
Consuming medications recognised to modulate neuromodulators
Hearing loss greater than 60dBHL |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tinnitus Loudness, Tinnitus Functional Index |
Post-treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tinnitus Loudness, Tinnitus Functional Index |
1-month post-treatment follow-up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/01/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [himanshu.dudeja14@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a multi-group pretest-post test, triple-blinded, randomized controlled trial (RCT) to evaluate the efficacy of available Vagus Nerve Stimulation and acoustic stimuli coupling in reducing tinnitus-related distress for three different sub-types of chronic subjective tinnitus. 60 patients will be randomly assigned to any of the three intervention groups: VNS + Matched noise, VNS + Notched noise, and Tinnitus Educational Counselling. VNS is a non-invasive transcutaneous auricular Vagus Nerve Stimulation provided using a Neurostim device at Cymba Concha of the left ear at a max comfortable level. Matched noise is a 1-octave band of white noise focused on the tinnitus frequency, and Notched noise is a white noise with a 1-octave exclusion focused on the tinnitus frequency presented at 5dB SL (re: tinnitus frequency threshold) using custom-made MATLAB code routed to an audiometer via an insert earphones. The intervention will be implemented over 3 weeks in a 3-2-1 sessions/week sequence, and outcomes will be measured at post-treatment and at an on-call 1-month follow-up. |