| CTRI Number |
CTRI/2023/04/052001 [Registered on: 26/04/2023] Trial Registered Prospectively |
| Last Modified On: |
20/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out early hearing loss in patients with a particular autoimmune disease by performing multiple hearing tests |
|
Scientific Title of Study
|
Use of behavioural and physiological hearing tests for early detection of asymptomatic sensorineural hearing loss in systemic lupus erythematosus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARVATHI R NAIR |
| Designation |
Post graduate |
| Affiliation |
KMC, MANIPAL |
| Address |
DEPARTMENT OF ENT AND HEAD AND NECK SURGERY, KMC, MANIPAL, UDUPI
ROOM NO. 506, NIH HOSTEL BLOCK A, KMC, MANIPAL, UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
7025109794 |
| Fax |
|
| Email |
parvathynair1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KAILESH PUJARY |
| Designation |
Professor and HOD |
| Affiliation |
KMC, MANIPAL |
| Address |
DEPARTMENT OF ENT AND HEAD AND NECK SURGERY, KMC, MANIPAL, UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
9845144015 |
| Fax |
|
| Email |
kailesh.pujary@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR PARVATHI R NAIR |
| Designation |
Post graduate |
| Affiliation |
KMC, MANIPAL |
| Address |
DEPARTMENT OF ENT AND HEAD AND NECK SURGERY, KMC, MANIPAL, UDUPI
ROOM NO. 506, NIH HOSTEL BLOCK A, KMC, MANIPAL, UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
7025109794 |
| Fax |
|
| Email |
parvathynair1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE, MANIPAL, UDUPI, KARNATAKA, 576104 |
|
|
Primary Sponsor
|
| Name |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
KASTURBA MEDICAL COLLEGE, MANIPAL, UDUPI, KARNATAKA, 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Parvathi R Nair |
KASTURBA MEDICAL COLLEGE, MANIPAL, |
DEPT OF ENT & HEAD & NECK SURGERY, SPEECH AND AUDIOLOGY, DEPT OF MEDICINE (DIV. OF RHEUMATOLOGY)
Udupi
KARNATAKA |
7025109794
parvathynair1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS DIAGNOSED WITH SLE AND IS ON TREATMENT. |
|
| ExclusionCriteria |
| Details |
1) OTHER AUTOIMMUNE DISEASES
2) OTHER CAUSES OF HEARING LOSS
3) PRIOR HISTORY OF OTOLOGIC PROCEDURES |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
PREVALENCE OF SENSORINEURAL HEARING LOSS IN PATIENTS WITH SLE USING ADVANCED AUDIOMETRIC ANALYSIS
EFFICIENCY AND CLINICAL USEFULNESS OF AUDIOMETRIC TESTS TO INCORPORATE IT INTO ROUTINE AUDIOLOGIC EXAMINATION |
1-2 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASSESS SLE DISEASE ACTIVITY USING PHYSICIAN GLOBAL ASSESSMENT (PGA) SCALE AND CORRELATE WITH OCCURENCE OF HEARING LOSS IN DIFFERENT SEVERITY |
1 DAY |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/06/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Otologic manifestations of autoimmune disorders is a rare disease entity. Later the presentation, worse the prognosis in such cases especially since the pathogenesis is unclear.
Systemic lupus erythematosus (SLE) is associated with several comorbidities, including hearing and vestibular disorders
Ear damage in SLE patients has been occasionally reported. However, the frequency and the mechanisms of ear involvement are not well documented.
Andonopoulus et al. in a controlled study showed that 23 out of 40 SLE patients (57.5 per cent) had impaired hearing, which was not associated with the presence of vasculitis, other disease systemic manifestations, or with the presence of anti ds-DNA antibodies. They concluded that these findings are probably attributed to a possible subclinical cochlear hydrops.
In a comparative study, Hearing Loss was found in about one fourth of SLE patients. The majority of patients had a SNHL affecting the middle and mainly the high frequencies. Audiometric tests have shown that more than half of SLE patients have chronic sensorineural hearing impairment, often asymptomatic. |