Comparison of the effect of coenzyme Q10 and placebo in the treatment of sudden sensorineural hearing loss and hearing-related quality of life
Design
In this double blinded randomized clinical trial with parallel control groups, phase 3, 60 patients with sudden sensorineural hearing loss will be assigned to the intervention and control groups using the envelope method. The intervention group will receive routine treatment plus coenzyme Q10 and the control group will receive routine treatment plus placebo.
Settings and conduct
This study will be performed in Besat Hospital in Hamadan on patients with sudden sensorineural hearing loss. Patients will be randomly allocated into two groups. The intervention group will receive routine treatment plus coenzyme Q10 and the control group will receive routine treatment plus placebo. Both groups will be evaluated for treatment outcome 3 and 6 months later. The study will be double-blind, the outcome assessor and the patient themselves will be unaware of receiving coenzyme Q10 or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria will be Sudden unilateral sensorineural hearing loss according to audiological criteria, age 18 to 70 years and less than one month after the onset of the disease. Conditions of non-entry: History of other ear diseases, the presence of any mass or other pathology in MRI of the ear and conductive hearing loss
Intervention groups
The intervention group, in addition to routine treatment, which includes weekly (for three weeks) injection of dexamethasone into the middle ear, will receive coenzyme Q10 at a dose of 100 mg once daily for 4 weeks. In the control group, routine treatment will be performed similar to the intervention group and they will receive a placebo instead of coenzyme Q10.
Main outcome variables
Main outcome will be changes in hearing status and hearing threshold based on audiograms results.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N23
Registration date:2022-05-23, 1401/03/02
Registration timing:registered_while_recruiting
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of coenzyme Q10 and placebo on the hearing status of patients with sudden sensorineural hearing loss
Public title
The effect of coenzyme Q10 on sudden sensorineural hearing loss treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral Sudden sensorineural hearing loss
Age 18-70 Years
Less than one month has passed since the onset of symptoms
Exclusion criteria:
History of other ear diseases
Presence of a mass or other pathology on ear MRI
Conductive hearing loss
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 cards will be prepared and write letter I on 30 for intervention and on the other 30 letter C for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, randomly select one of the envelopes and open it, based on selected letter ( I or C) patients will be allocated it to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be performed double blind, the person who evaluating the outcome of treatment will be unaware of the intervention and control groups. Also participants will be blinded to receiving coenzyme Q10 or placebo according to the same packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
ُShahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2022-05-08, 1401/02/18
Ethics committee reference number
IR.UMSHA.REC.1401.135
Health conditions studied
1
Description of health condition studied
sudden sensorineural hearing loss
ICD-10 code
H90.3
ICD-10 code description
Sensorineural hearing loss, bilateral
Primary outcomes
1
Description
Changes in PTA and SRT auditory parameters
Timepoint
3 and 6 months after starting treatment
Method of measurement
Through audiometry and audiogram parameters
Secondary outcomes
1
Description
Hearing-related quality of life
Timepoint
3 and 6 months after starting treatment
Method of measurement
By asking a question: Over the past week, how much has the problem of hearing loss and deafness affected your quality of life in communicating with friends, family and colleagues? And responses on the Likert scale will range from very low to very high.
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
dr Elnaz Shariatpanahi
Street address
shahid Beheshti Blvd
City
Hamedan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
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