| CTRI Number |
CTRI/2020/06/026135 [Registered on: 25/06/2020] Trial Registered Prospectively |
| Last Modified On: |
20/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To identify Hidden Hearing Loss in young adults with different types of recreational noise exposures. |
|
Scientific Title of Study
|
Comparison of extended high frequency thresholds of hearing and electrophysiological tests among young adults with and without recreational noise exposure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shireen Chopra |
| Designation |
Student |
| Affiliation |
MCHP,MAHE |
| Address |
Department of Speech and Hearing,MCHP,MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9810444839 |
| Fax |
|
| Email |
chopra.shireen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Rajashekhar |
| Designation |
Professor |
| Affiliation |
MCHP,MAHE |
| Address |
Department of Speech and Hearing,MCHP,MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845547736 |
| Fax |
|
| Email |
b.raja@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Priya G |
| Designation |
Associate Professor |
| Affiliation |
MCHP,MAHE |
| Address |
Department of Speech and Hearing,MCHP,MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9480041575 |
| Fax |
|
| Email |
priya.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing,Manipal College of Health Professions,Manipal Academy of Higher Education,Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
Shireen Chopra |
| Address |
MCHP,MAHE,Manipal |
| Type of Sponsor |
Other [self (Shireen Chopra)] |
|
|
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 |
| Shireen Chopra |
Kasturba Hospital |
Room no-309,312,CTC,third floor,Department of Speech and Hearing.
Udupi
KARNATAKA |
9810444839
chopra.shireen@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Exposed to high and low recreational noise. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
2 groups of participants(with normal audiometric thresholds) will be included in this study – 1 group with minimal or no exposure to recreational noise and another group with exposure to recreational noise. Participants will be screened using NESI (Noise Exposure Structured Interview). |
|
| ExclusionCriteria |
| Details |
Participants with hearing loss or any middle ear pathology.
H/o any neurological ailment.
H/o any other medical conditions which could lead to high frequency hearing loss (BP, heart/liver/kidney problems, exposure to any ototoxic drugs.)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of Hidden Hearing Loss in young adults who are exposed to recreational noise will provide us information regarding their hearing status at high frequencies. |
2 visits will be required by the patient,40 mins each. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
05/08/2020 |
| 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
|
Not Yet Published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PROJECT TITLE- Comparison of extended high frequency thresholds of hearing and electrophysiological tests among young adults with and without recreational noise exposure. AIM- To compare the extended high frequency findings with electrophysiological tests among young healthy adults with and without recreational noise. PURPOSE- To look at the efficacy of extended high frequency audiometry and electrophysiological measures for hidden hearing loss (HHL) and to get to a confirm diagnosis. RESEARCH FINDINGS- Exposure to music is also reported to cause HHL. Some of the common audiological findings of this population are as follows-high frequency thresholds (beyond 8k) found to be poorer,ABR wave one ratio amplitude reduced , ECochG-larger SP/AP ratio. CRITERIA AND PROCEDURE- Students will be recruited through poster advertisement.NESI would be used to screen the students and divide them into high and low recreational noise exposure groups. Test battery approach including –Pure Tone Audiometry (250-8k), Extended High Frequency Audiometry (8-20k), ABR (wave 1 and wave 5 amplitude and latency ratio was calculated) and EcochG (SP/AP ratio was calculated) was administered for both the groups. OUTCOME- Identification of Hidden Hearing Loss (HHL) in young adults who are exposed to recreational noise will provide us information regarding their hearing status at high frequencies. HHL, if identified in the study population, can be used to prevent further damage to hearing by providing hearing protection counselling. |