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CTRI Number  CTRI/2024/09/074484 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How hearing loss and hearing problems affects how people feel sensitive to emotions and their surroundings.  
Scientific Title of Study   Correlation between sensory processing sensitivity and perceived hearing handicap in adults with acquired hearing loss 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajay Krishnan 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education Manipal Udupi Karnataka 567104 India

Udupi
KARNATAKA
576104
India 
Phone  9745620554  
Fax    
Email  ajay.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ms Bhargavi PG 
Designation  Assistant Professor - Selection Grade 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education Manipal Udupi Karnataka 567104 India

Udupi
KARNATAKA
567104
India 
Phone  9964237695  
Fax    
Email  bhargavi.pg@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms Bhargavi PG 
Designation  Assistant Professor - Selection Grade 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education Manipal Udupi Karnataka 567104 India


KARNATAKA
567104
India 
Phone  9964237695  
Fax    
Email  bhargavi.pg@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions Madhav Nagar Manipal Udupi Karnataka India 576104  
 
Primary Sponsor  
Name  Ajay Krishnan 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, 567104, India 
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 Hari Prakash P  Kasturba Hospital  Department of speech and hearing, Room no 27,Second floor, New OPD, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka, India, 567104 Udupi
Udupi
KARNATAKA 		 9886135522

hari.prakash@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H839||Unspecified disease of inner ear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Person with hearing loss greater than a mild degree
2.Age: 18 to 65 years
3.Minimal education till 10th (as per the Flesch score obtained for both scales used)
4.Should be able to Comprehend English
 
 
ExclusionCriteria 
Details  1.No comorbid medical or mental conditions
2.Sudden hearing loss
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The questionnaires mentioned in the protocol gives us scores based on subject response. Scores are obtained from both HHIA and HSP tools. these scores are used to find correlation between hearing handicap and sensory sensitivity  Study would take a time period of 9 months starting from October 2024 to June 2025 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="145"
Sample Size from India="145" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="71" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2024 
Date of Study Completion (India) 17/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Title: Correlation between Sensory Processing Sensitivity and Perceived Hearing Handicap in Adults with Acquired Hearing Loss

Type: Prospective, Cross-Sectional Study

Objectives:

  • To explore the correlation between sensory processing sensitivity and perceived hearing handicap in adults with acquired hearing loss.
  • To use the Highly Sensitive Person Scale to assess sensory processing sensitivity and the Hearing Handicap Inventory to measure perceived hearing handicap.

Justification:

  • This study addresses a gap in understanding the relationship between sensory processing sensitivity and perceived hearing handicap, particularly in adults with acquired hearing loss. Previous research has not extensively explored these changes or their interrelation.

Study Details:

  • Departments Involved: Department of Speech and Hearing
  • Study Period: June 2024 – April 2025
  • Sample Size: 145 participants, accounting for a 15% dropout rate
  • Inclusion Criteria: Adults aged 18-65 with moderate to severe hearing loss, educated at least until the 10th grade, and able to comprehend English.
  • Exclusion Criteria: Individuals with comorbid medical or mental conditions and those with sudden hearing loss.
  • Statistical Methods: Karl Pearson or Spearman Rank correlation
  • Tools Used: Highly Sensitive Person Scale and Hearing Handicap Inventory for Adults

Procedure:

  • Participants will be recruited from the Department of Speech and Hearing (Audiology OPD), and after fulfilling inclusion criteria, they will complete the two questionnaires. The process, including answering and comprehension, is expected to take about 25 minutes.

Outcome Measures:

  • The study will assess participants’ emotional and environmental sensitivity and their perceived hearing handicap.

Ethical Considerations:

  • IEC clearance and CTRI registration will be obtained before participant recruitment.

Literature Review Summary

  1. Bilgehan Tekin Dal (2023):

    • This study explored sensory processing abilities in adults with acquired hearing loss using the Adolescent/Adult Sensory Profile. Findings indicated that hearing-impaired individuals showed significant reductions in processing various environmental stimuli compared to controls.

  2. Anu Sharma and Hannah Glick (2016):

    • They investigated cross-modal rearrangement in people with hearing loss and discussed how different brain regions adapt to hearing impairment. They observed variations in cross-modal plasticity but did not focus on sensory and emotional sensitivity.

  3. Bianca Acevedo (2014):

    • This study examined neural activation patterns in conditions including PTSD, schizophrenia, ASD, and sensory processing sensitivity. Unique neural activations for sensory processing sensitivity were identified, emphasizing the need for more research into its distinct neural responses and implications for environmental sensitivity and emotional reactivity.
 
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