Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000291189
Ethics application status
Approved
Date submitted
19/02/2019
Date registered
26/02/2019
Date last updated
6/07/2021
Date data sharing statement initially provided
26/02/2019
Date results information initially provided
6/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effects of primer sjögren's syndrome on the hearing and balance system
Scientific title
INVESTIGATION OF PRIMARY SJOGREN SYNDROME EFFECTS ON HEARING AND VESTIBULAR SYSTEMS
Secondary ID [1] 297139 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary sjögren's syndrome 311607 0
Condition category
Condition code
Inflammatory and Immune System 310233 310233 0 0
Autoimmune diseases
Ear 310234 310234 0 0
Other ear disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is included that 35 volunteer patients(18-65 ages) diagnosed with primary Sjögren's syndrome by the Rheumatology clinic. Audiometry, Tympanometry, stapes reflex, VHIT (video head impulse test), cVEMP (cervical vestibular evoked myogenic potentials), and oVEMP (ocular vestibular evoked myogenic potentials) tests will be performed to patients following the ear-nose-throat examination. None of these tests are invasive tests. These tests keep on approximately 45 minutes.
Intervention code [1] 313685 0
Diagnosis / Prognosis
Comparator / control treatment
35 healthy volunteers with similar age and gender with patients group will be included as a control group.
Control group
Active

Outcomes
Primary outcome [1] 319154 0
Detection of sensorineural hearing loss in the patients. The audiometry, tympanometry and stapes reflex tests will be used for this examination.
Timepoint [1] 319154 0
After ear nose throat examination, the hearing test of the individuals will be performed by the audiologist.
Secondary outcome [1] 367024 0
In order to detection of vestibular pathology, balance test (VEMP, VHIT) will be performed to individuals. Especially, it is important that the waves of VEMP are not obtained or detecting the increased latency time of waves or detection of asymmetric in semicircular canal's gain.
Timepoint [1] 367024 0
After the hearing test, the balance test of the individuals will be performed by the audiologist.

Eligibility
Key inclusion criteria
Individuals who primary Sjogren syndrome diagnosis
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. Conductive hearing loss
b. Patients with perforated tympanic membrane
c. Uncontrolled HT and/or diabetes mellitus
D. Patients with a previously diagnosed neuro-otological disease
e. Individuals who underwent head trauma
f. Individuals who performed cervical or eye-related surgery
g. Under 18 years and over 65 years

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2019
Actual
4/03/2019
Date of last participant enrolment
Anticipated
Actual
24/11/2020
Date of last data collection
Anticipated
Actual
26/11/2020
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 21287 0
Turkey
State/province [1] 21287 0
Konya

Funding & Sponsors
Funding source category [1] 301699 0
University
Name [1] 301699 0
Selcuk University
Country [1] 301699 0
Turkey
Primary sponsor type
University
Name
Selcuk University
Address
Selcuk University Faculty of Medicine. Akademi Mah. Yeni Istanbul Cad. No:369 Post Code:42130
Selçuklu-Konya / TURKEY
Country
Turkey
Secondary sponsor category [1] 301423 0
None
Name [1] 301423 0
Address [1] 301423 0
Country [1] 301423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302418 0
Selcuk University Faculty of Medicine
Ethics committee address [1] 302418 0
Alaeddin Keykubat Campus, Akademi Mah. Yeni Istanbul Cad. No:369 Post Code:42130
Selçuklu-Konya / TURKEY
Ethics committee country [1] 302418 0
Turkey
Date submitted for ethics approval [1] 302418 0
30/05/2018
Approval date [1] 302418 0
27/06/2018
Ethics approval number [1] 302418 0
2018/252

Summary
Brief summary
This study is included that 35 volunteer patients diagnosed with primary Sjogren's syndrome by the Rheumatology and 35 healthy volunteers with similar age and gender as a control group. Audiometry, Tympanometry, stapes reflex, VHIT (video head impulse test), cVEMP (cervical vestibular evoked myogenic potentials), and oVEMP (ocular vestibular evoked myogenic potentials) tests will be performed following the ear-nose-throat examination. None of these tests are invasive tests.
As a result of this study, hearing and balance functions in patients with primary Sjogren diagnosis will be examined in comparison with the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90178 0
Dr Bülent Ulusoy
Address 90178 0
Selcuk University faculty of medicine, Department of Otorhinolaryngology Head -Neck Surgery, Alaeddin Keykubat CAMPUS, Akademi Mah. Yeni Istanbul Cad. No:369 Post Code:42130
Selçuklu-Konya / TURKEY
Country 90178 0
Turkey
Phone 90178 0
+905065097893
Fax 90178 0
Email 90178 0
[email protected]
Contact person for public queries
Name 90179 0
Dr Bülent Ulusoy
Address 90179 0
Selcuk University faculty of medicine, Department of Otorhinolaryngology Head -Neck Surgery, Alaeddin Keykubat CAMPUS, Akademi Mah. Yeni Istanbul Cad. No:369 Post Code:42130
Selçuklu-Konya / TURKEY
Country 90179 0
Turkey
Phone 90179 0
+905065097893
Fax 90179 0
Email 90179 0
[email protected]
Contact person for scientific queries
Name 90180 0
Dr Bülent Ulusoy
Address 90180 0
Selcuk University faculty of medicine, Department of Otorhinolaryngology Head -Neck Surgery, Alaeddin Keykubat CAMPUS, Akademi Mah. Yeni Istanbul Cad. No:369 Post Code:42130
Selçuklu-Konya / TURKEY
Country 90180 0
Turkey
Phone 90180 0
+905065097893
Fax 90180 0
Email 90180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.