| CTRI Number |
CTRI/2024/09/073679 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study how Type 2 Diabetes affects hearing and sound processing |
|
Scientific Title of Study
|
Central auditory processing abilities in Type 2 Diabetes Mellitus - An exploratory study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Els Marry Suresh |
| Designation |
Student pursuing MSc Audiology |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of speech and hearing Manipal College of Health Professions MAHE
Manipal Karnataka
India 576104
Udupi
KARNATAKA
576104
India |
| Phone |
6235395784 |
| Fax |
|
| Email |
els.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Prakash P |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of speech and hearing Manipal College of Health Professions MAHE
Manipal Karnataka
India 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886135522 |
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hari Prakash P |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of speech and hearing Manipal College of Health Professions MAHE
Manipal Karnataka
India 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886135522 |
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education
Manipal Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Els Marry Suresh |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal Karnataka India- 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Hari Prakash P |
Kasturba Hospital |
Department of Speech and Hearing, 3rd floor, Above A2 ward, CTC Building, Baliga block, Kasturba hospital, Madhav Nagar, Manipal, Karnataka, India 576104
Udupi KARNATAKA
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants of 45-60 years |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group 1 - T2DM
Age of 45 to 60 years
Native Kannada speakers with at least 12th standard education
Hearing loss less than Mild degree (less than 25dBHL) for Puretone averages of 500Hz 1kHz and 2kHz
Duration of T2DM of minimum 2 years
Individuals with T2DM having HBA1c levels greater than 6.5percentage
Individuals with and without medication for T2DM
Group 2 - normal individuals
Age of 45 to 60 years
Native Kannada speakers with at least 12th standard education
Hearing loss less than Mild degree (less than 25dBHL) for Puretone averages of 500Hz 1kHz and 2kHz.
Individuals with no diabetes mellitus (self reported)
|
|
| ExclusionCriteria |
| Details |
Group 1 - T2DM
Associated neuropathies (reports)
Hypertension (self reported /reports)
Early dementia (self reported/reports)
Individuals with intake of ototoxic drugs (Example:cisplatin, loop diuretics)
Treatment with insulin and oral hypoglycemic agents
Group 2 - normal individuals
Hypertension (self reported)
Early dementia (self reported)
Individuals with intake of ototoxic drugs (Example:cisplatin, loop diuretics)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The auditory processing abilities are measured as scores for DDT, ATTR and PPT
The SPIN test is measured as SNR loss
The questionnaires administered on diabetes individuals provide an outcome measure of annual noise exposure and cognitive decline in scores |
The above mentioned tests will be done at a single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
25/09/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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
|
1. Title: Central Auditory Processing Abilities in Type II Diabetes Mellitus – An Exploratory Study 2. Type of Study: Prospective, cross-sectional study 3. Aims & Objectives Primary Objective: Explore and compare auditory processing abilities in individuals with Type 2 Diabetes Mellitus (T2DM) and without diabetes. Secondary Objective: Investigate the relationship between auditory processing, cognitive abilities, and lifestyle (noise exposure) in T2DM patients. 4. Justification: Existing studies by Workman et al. (2017) and Pirasteh et al. (2018) indicate deterioration in auditory processing abilities among individuals with T2DM, but comprehensive understanding is lacking. This study aims to bridge this gap, highlighting how cognitive impairments associated with T2DM affect auditory processing, essential for better management strategies. 5. Departments Involved: - Center for Podiatry & Diabetic Foot Care & Research, MAHE
- Department of Speech and Hearing, MCHP, MAHE
6. Study Period: - Reviews and approvals: 2-3 months
- Data collection: June 2024 – February 2025
- Analysis and manuscript submission: March 2025
7. Sample Size: - Total: 62 participants (31 T2DM, 31 control)
- Calculated using power study and significance level parameters from Mishra et al. (2016)
8. Materials and Methods: Inclusion Criteria: - T2DM Group: Aged 45-60, native Kannada speakers, mild hearing loss, minimum 2 years T2DM duration, HBA1c > 6.5%
- Control Group: Aged 45-60, native Kannada speakers, mild hearing loss, no diabetes
Exclusion Criteria: - T2DM Group: Neuropathies, hypertension, early dementia, ototoxic drug intake, treatment with insulin/oral hypoglycemic agents
- Control Group: Hypertension, early dementia, ototoxic drug intake
Statistical Methods: - Data analysis using SPSS or Jamovi
- T-tests, correlation analysis, MANOVA to compare auditory processing tests controlling for age, noise exposure, and cognitive ability
Tools: - Noise Exposure Questionnaire (NEQ) by Tiffany et al. (2017)
- Montreal Cognitive Assessment (MoCA) by Nasreddine et al. (2005)
9. Procedure: Participants will be recruited from specified centers, screened based on criteria, and undergo auditory processing tests (SPIN, ATTR, PPT, DDT). NEQ and MoCA questionnaires will assess noise exposure and cognitive abilities for the T2DM group. The entire procedure will last 45 minutes to 1 hour, with breaks as needed. Data will be analyzed to compare performances between T2DM and control groups. 10. Outcome Measures: - Scores for DDT, ATTR, PPT
- SNR loss for SPIN test
- Noise exposure and cognitive decline scores from questionnaires
11. Risks and Benefits: - Risks: Minimal, primarily discomfort due to the procedure duration
- Benefits: Participants receive information on auditory processing, cognition, and hearing levels, contributing to better understanding and management strategies
12. Ethical Considerations: - Clearances from IEC, IRC, and CTRI
- Informed consent obtained from participants
- Confidentiality maintained
- Data reviewed only by authorized personnel
13. Budget and Funding: Not applicable 14. Literature Review: Research indicates a higher likelihood of hearing loss and cognitive impairments among T2DM individuals, affecting their quality of life Studies by Mishra et al. (2016), Yaffe et al. (2020), Srikanth et al. (2020), and Moheet et al. (2015) show poor performance in temporal resolution tasks and other cognitive domains among diabetic patients. This study aims to fill the research gap by considering multiple covariant factors together, enhancing understanding of the complex interactions between T2DM and auditory processing. |