Investigation of hearing loss changes in ULTRAHIGH frequency in patients with chronic renal failure in terms of number of dialysis and duration of illness
Determination of hearing changes in ULTRAHIGH frequency in patients with chronic renal failure according to the number of dialysis sessions and the duration of the disease.
Design
Clinical trial without control group, with one group, without blinding, non-random, without phase on 20 patients
Settings and conduct
In this study, 20 patients under the age of 60 with chronic renal failure who are on dialysis in Khatam and Razavi hospitals of Shahroud and Damghan Velayat hospital are studied. Patients underwent pure tone audiometric (PTA) test twice. One hearing test is done before dialysis and the next time after 4 months.
Participants/Inclusion and exclusion criteria
Admission: Patients under 60 years of age with chronic renal failure undergoing dialysis.Absence: History of hearing loss due to exposure to loud noise, hereditary and genetic diseases of hearing loss, acquired hearing loss for any reason before referral, use of autotoxic drugs such as furosemide and aminoglycosides for more than a week, tinnitus Permanent, kidney transplant, chronic ear infection, mental disability
Intervention groups
20 patients with chronic renal failure undergoing dialysis undergo PTA at high frequencies (2000-8000 Hz) to assess their hearing changes
Main outcome variables
Hearing changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201112049369N1
Registration date:2020-12-22, 1399/10/02
Registration timing:retrospective
Last update:2020-12-22, 1399/10/02
Update count:0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Sanaz Koroji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 7153
Email address
dr.sanazkoroji@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
2020-07-22, 1399/05/01
Actual recruitment end date
2020-11-21, 1399/09/01
Trial completion date
2020-11-21, 1399/09/01
Scientific title
Investigation of hearing loss changes in ULTRAHIGH frequency in patients with chronic renal failure in terms of number of dialysis and duration of illness
Public title
Investigation of hearing loss changes in ULTRAHIGH frequency in patients with chronic renal failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with chronic renal failure under the age of 60 who are on dialysis
Exclusion criteria:
History of hearing loss following loud exposure
Having inherited or genetic diseases of hearing loss
Acquired hearing impairment for any reason before referral
Taking autotoxic drugs such as furosemide and aminoglycosides for more than a week
Having persistent tinnitus
Kidney transplant
Chronic ear infection
intellectual disability
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud Islamic Azad University of medical sciences
Street address
Shahroud Islamic Azad University,University blvd,Shahroud,Semnan
City
Shahroud
Province
Semnan
Postal code
43189-36199
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1398.063
Health conditions studied
1
Description of health condition studied
Evaluation of hearing changes in patients with chronic renal failure undergoing dialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hearing changes in patients with chronic renal failure undergoing dialysis
Timepoint
Perform audiometry before dialysis at the beginning of the study and 4 months later
Method of measurement
Pure tone audiometry test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 patients with chronic renal failure under the age of 60 who are on dialysis under one period of pure tone audiometry (PTA) test at high frequencies (2000-8000Hz) at the beginning of the study before dialysis and the next time after 4 months Placed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Shahroud Hospital
Full name of responsible person
Sanaz Koroji
Street address
Central dormitory of Islamic Azad University، University Blvd., Shahroud
City
Shahroud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 4536
Email
dr.sanazkoroji@gmail.com
2
Recruitment center
Name of recruitment center
Velayat Damghan Hospital
Full name of responsible person
Sanaz Koroji
Street address
Central dormitory of Islamic Azad University، University Blvd., Shahroud
City
Shahroud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 4536
Email
dr.sanazkoroji@gmail.com
3
Recruitment center
Name of recruitment center
Razavi Shahroud Hospital
Full name of responsible person
Sanaz Koroji
Street address
Central dormitory of Islamic Azad University، University Blvd., Shahroud
City
Shahroud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 4536
Email
dr.sanazkoroji@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sanaz Koroji
Street address
Central dormitory of Islamic Azad University، University Blvd., Shahroud
City
Shahroud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 4536
Email
dr.sanazkoroji@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sanaz Koroji
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
Central dormitory of Shahroud Azad University, University Blvd., Shahroud
City
Shahroud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 4536
Email
dr.sanazkoroji@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sanaz Koroji
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
Central dormitory of Shahroud Azad University, University Blvd., Shahroud
City
Shahroud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 4536
Email
dr.sanazkoroji@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sanaz Koroji
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
Central dormitory of Shahroud Azad University, University Blvd., Shahroud
City
Shahroud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 4536
Email
dr.sanazkoroji@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available