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CTRI Number  CTRI/2023/06/053390 [Registered on: 01/06/2023] Trial Registered Prospectively
Last Modified On: 23/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study on association of comorbidities with Hearing loss in Geriatric population 
Scientific Title of Study   A study on frailty, cognitive dysfunction and associated comorbidities with Hearing loss in Geriatric population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kapil Sikka 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  4060, Teaching Block, Department of ENT
AIIMS, Ansari Nagar
South
DELHI
110029
India 
Phone  9810423088  
Fax    
Email  kapil_sikka@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kapil Sikka 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  4060, Teaching Block, Department of ENT
AIIMS, Ansari Nagar
South
DELHI
110029
India 
Phone  9810423088  
Fax    
Email  kapil_sikka@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kapil Sikka 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  4060, Teaching Block, Department of ENT
AIIMS, Ansari Nagar
South
DELHI
110029
India 
Phone  9810423088  
Fax    
Email  kapil_sikka@yahoo.com  
 
Source of Monetary or Material Support  
ICMR - Monetary Support AIIMS, NEW DELHI - Material Support  
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
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 
KAPIL SIKKA  AIIMS, NEW DELHI  DEPARTMENT OF OTORHINOLARYNGOLOGY HEAD NECK SURGERY, AIIMS, NEW DELHI
South
DELHI 		 9810423088

kapil_sikka@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS, NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H838||Other specified diseases of innerear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  (Group 1)
-Individuals with age >60 years
-Individuals without the complain of hearing loss
(Group 2)
-Individuals with age >60 years
-Individuals with sensorineural or mixed hearing loss
 
 
ExclusionCriteria 
Details  (Group 1)
-Individuals with ear related complain
-No consent for the study
(Group 2)
-No consent for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study is expected to give the overview of the hearing impairment diagnosis and management of hearing impairment in older adults along with the other comorbidities. The study will highlight the impact of other physical and mental condition and the limitation that it imposes on the diagnosis of hearing loss as well as the rehabilitation process with the appropriate hearing assistive device such as hearing aids. It will help us to analyse the factors pertaining to the other health conditions that play a major role in management of hearing loss in these individuals. We expect to establish a correlation between general poor mental and physical health in patients with hearing loss compared to those without it. Also, cognitive domain is likely to be significantly impaired in hearing loss group of individuals.   The first two years of the study will focus on data collection and the third year will be for the compilation and analysis of the data along with the final report writing. 
 
Secondary Outcome  
Outcome  TimePoints 
It will help us to analyse the factors pertaining to the other health conditions that play a major role in management of hearing loss in these individuals. We expect to establish a correlation between general poor mental and physical health in patients with hearing loss compared to those without it. Also, cognitive domain is likely to be significantly impaired in hearing loss group of individuals.   The first two years of the study will focus on data collection and the third year will be for the compilation and analysis of the data along with the final report writing. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/07/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hearing loss is one of the most common sensory deficits in older adults. It significantly affects the quality of life and needs equal attention. However, the diagnosis and rehabilitation of hearing impairment in older adults is not independent of other comorbidities expected in this group. The identification of hearing loss, diagnosis through proper test battery and rehabilitation with appropriate hearing device is majorly dependant on the overall physical and mental health of the individuals. Novelty: Cognitive decline and its impact on hearing impairment in older adults is being studied intensively. However, fewer researches have focused on overall health and its impact on age related hearing loss in older adults. Authors and co-authors (Prof. Alok Thakar) have led the ICMR task force project investigating hearing loss in India population at various centres. A major factor causing hearing loss in India has been identified as presbycusis. There is hence a need to study geriatric hearing loss further. Objective: Therefore, this study is focused at assessing the cross section of the individuals with age >60 years who complain of hearing loss and the ones who do not have any ear related complains. Physical and mental health will be evaluated for both the cohort and its impact on diagnosis and management of hearing loss will be studied using appropriate questionnaires and standardized scales and tests. Method:  Audiological test battery including the Pure Tone Audiometry, Speech audiometry, Impedance audiometry and reflex testing will be done. Along with this the Frailty index will be calculated using the Fried criteria, disability in instrumental activities of daily living (IADL) will be measured using the Lawton and Brody scale and cognitive decline will be assessed using the Hindi Mental State Examination (HMSE). Also a questionnaire pertaining to awareness, willingness and benefits of hearing aid will be administered. All the data will be tabulated and correlation analysis will be done. Further, there is lack of data on usage assistive device and amplification device like hearing aid in hearing impaired population. Therefore, in this study as secondary objective, we wish to evaluate factors pertaining to this.

 
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