| CTRI Number |
CTRI/2024/12/077854 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study Testing How Well People with COPD or Lung disease can Hear and Think Clearly |
|
Scientific Title of Study
|
Assessment of Auditory and Cognitive Function in Stable Chronic Obstructive Pulmonary Disease Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. ILA JOSHI |
| Designation |
PhD Scholar |
| Affiliation |
Department of Physiology, NIMS University,Rajasthan |
| Address |
First floor, Dept. of Physiology, NIMS University, Jaipur Delhi Highway
Jaipur
RAJASTHAN
303121
India |
| Phone |
9602838922 |
| Fax |
|
| Email |
sharma.dr01061991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinita Ailani |
| Designation |
Professor |
| Affiliation |
Department of Physiology, NIMS University, Rajasthan |
| Address |
First Floor, Dept. of Physiology, NIMS University, Jaipur Delhi Highway, Rajasthan
Jaipur
RAJASTHAN
303121
India |
| Phone |
9829365666 |
| Fax |
|
| Email |
ailanivinita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ILA JOSHI |
| Designation |
PhD Scholar |
| Affiliation |
Department of Physiology, NIMS University, Rajasthan |
| Address |
First Floor, Dept. of Physiology, NIMS University, Jaipur Delhi Highway, Rajasthan
Jaipur
RAJASTHAN
303121
India |
| Phone |
9602838922 |
| Fax |
|
| Email |
sharma.dr01061991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multi Disciplinary Research Unit, Second floor, RUHS-CMS, Pratap Nagar, Jaipur, India, Pin Code: 302033 |
|
|
Primary Sponsor
|
| Name |
Department of Health Research(DHR) |
| Address |
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MDRU |
RUHS-CMS, Kumbha Marg, Pratap Nagar, Jaipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ila Joshi |
MDRU Lab, 2nd floor, teaching building |
RUHS-CMS, Sector-11,Kumbha Marg, Pratap Nagar, 302033
Jaipur
RAJASTHAN |
9602838922
sharma.dr01061991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHSCMSETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy with history of smoking and COPD |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Stable COPD patients reporting to the respiratory department OPD
Subjects with no hospitalization for COPD related illness in the last 6 months.
Healthy controls who are coming to the hospital with trivial illness or the attendants of patients with no history of COPD
|
|
| ExclusionCriteria |
| Details |
1.Patients presenting with acute exacerbation or any other complication of COPD like Cor pulmonale
2. Any other lung diseases patients like silicosis, asbestosis, restrictive lung diseases, and emphysema.
3. Patients with history of any traumatic lesion possibly affecting auditory functions, injury to tympanic membranes due to trauma, loud noise(more than 85dB), known to have decreased hearing due to infections in middle ear, and family history of hearing loss
4. History of ear surgery, or ototoxicity, intake of ototoxic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Auditory functions by using Oto-acoustic emission (OAE) and Brainstem evoked response audiometry (BERA) in stable COPD patients and compare them with healthy controls |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess cognitive functions in stable COPD patients vs. age matched healthy volunteers using Montreal Cognitive assessment questionnaire (MoCA) |
2 years |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The Study will be a hospital based prospective cross-sectional study and participants will be stable COPD patients and age, sex matched healthy controls(40-60yeras). In this study we will test the hearing ability of all the participants by using BERA and OAE machine and then with the help of Montreal Cognitive Assessment tool questionnaire(MOCA) we will assess the cognition. Oxidative stress will be measured by MDA levels measured in blood of the patients.
|