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CTRI Number  CTRI/2025/08/093600 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Memory Affects the Ability to Tolerate Background Noise in Older Adults 
Scientific Title of Study   Relationship Between Auditory Working Memory and Acceptable Noise Level in Older Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zainab Punnakkaparampil Faisal 
Designation  Post Graduate Student Pursuing MSc in Audiology 
Affiliation  Manipal College of Health Professions Manipal Academy of Higher Education 
Address  Department of Speech and Hearing Manipal College of Health Professions Madhav Nagar Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104

Udupi
KARNATAKA
576104
India 
Phone  7994168491  
Fax    
Email  Zainab.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Priya G 
Designation  Assistant Professor  
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing Manipal College of Health Professions Madhav Nagar Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104

Udupi
KARNATAKA
576104
India 
Phone  9480041575  
Fax    
Email  priya.g@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kishan MM 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing Manipal College of Health Professions Madhav Nagar Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104

Udupi
KARNATAKA
576104
India 
Phone  9845141575  
Fax    
Email  kishan.m@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal Udupi Karnataka India 576104  
 
Primary Sponsor  
Name  Zainab Punnakkaparampil Faisal 
Address  Department of Speech and Hearing Manipal College of Health Professions Madhav Nagar Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104  
Type of Sponsor  Other [Self] 
 
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 
Dr Kishan M M  Kasturba Hospital  Room no 27,2nd floor, Audiology OPD clinic,MAHE,Manipal,576104 Karnataka,India
Udupi
KARNATAKA 		 9845141575

kishan.m@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Older adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Older adults who have a MoCA score greater than 26

2.Pure-tone average of greater than 40 dB HL for each ear at frequencies of 0.5,1,2 and 4kHz, 
 
ExclusionCriteria 
Details  1.Individuals with significant ontological, neurological, psychological, or medical conditions.
2. Presence of any middle ear diseases. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Digit span- verbal short-term and working memory
ANL: Acceptable noise level score expressed in decibel.
SSQ: Speech, Spatial and Qualities 		 once at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   10/09/2025 
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="9"
Months="9"
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   This study aims to examine the relationship between acceptable noise level and auditory working memory  in older adults. Participants will be recruited from the Department of Speech and Hearing, Kasturba Hospital, during routine audiological evaluations. Eligibility will be determined through Pure-Tone Audiometry and the Montreal Cognitive Assessment . Written informed consent will be obtained from all participants.

Auditory working memory will be assessed using the Digit Span subtests and the Operation Span task. Acceptable Noise Level will be measured in an acoustically treated room using a recorded monologue with multi-talker babble noise presented in a free-field setup. Additionally, participants will complete the Speech, Spatial, and Qualities of Hearing Scale questionnaire.

Data will be analyzed using descriptive statistics, t-tests, ANOVA, correlations, and chi-square tests. 

Understanding how auditory working memory affects acceptable noise levels in older adults is key, as age-related hearing and cognitive declines reduce noise tolerance and hinder communication. This study may guide strategies to improve speech comprehension in noisy settings.
 
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