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Omega-3 Adjunctive Therapy in Sudden Sensory Neural Hearing Loss

Protocol summary

Study aim
Effectiveness of omega 3 adjunctive therapy in sudden sensory neural hearing loss"SSNHL"
Design
Study design: randomized double blind placebo control study. Randomization is done by a statistical software. Sample size is 78.
Settings and conduct
Place of the study: the emergency department and clinic of Amir Alam Hospital. Taking complete history of disease from patients with history of SSNHL by a physician who is blind to the intervention groups. Paraclinical tests: audiometric parameters such as PTA, SRT,SDS,TM and WRS and MRI after one week of medication; lab tests such as CBC, ESR, CRP,lipid profiles such as LDL, HDL, TG, and Chol and coagulation factors such as PT, PTT, and INR. Patients are blinded during study. Placebo (glycerin oil) and omega-3 have similar characteristics.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 18-70 years old; Sudden hearing loss within 12 hours, which suddenly occurred during the last month Exclusion criteria: Congenital deafness; Brain tumors;Taking anticoagulants; Metabolic diseases (Refsum disease); Inherited bleeding disorders; abnormal coagulation profile; corticosteroids contraindications; Lipid-lowering medications (intestinal agents, statins, niacin and fibrates); Lactation and Pregnancy; Allergy to fish and fish oil.
Intervention groups
Standard oral steroids through 10-Day program for all Patients. Intervention group: omega-3 will be orally administered 2000 mg/day in single daily dose in addition to steroid to 39 patients for one month. Control group: patients in the placebo group will receive steroid + placebo.If PTA shows improvement after 10 days,treatment with steroid will be continued orally. If there was no improvement, treatment will be changed to intratympanic dexamethasone, six injections every other day.
Main outcome variables
Pure Tone Audiogram; Speech Recognition Threshold; Word Recognition Score; Tympanogram; Acoustic Reflex Threshold

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180519039720N1
Registration date: 2018-09-09, 1397/06/18
Registration timing: prospective

Last update: 2018-09-09, 1397/06/18
Update count: 0
Registration date
2018-09-09, 1397/06/18
Registrant information
Name
Benyamin Rahmaty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 3352
Email address
b-rahmaty@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2019-08-06, 1398/05/15
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
empty
Scientific title
Omega-3 Adjunctive Therapy in Sudden Sensory Neural Hearing Loss
Public title
The Effectiveness of Omega-3 Therapy on Sudden Deafness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteers between 18 to 70 years old Sudden hearing loss over the last month
Exclusion criteria:
Other causes of hearing impairment, such as congenital deafness Brain tumors including cerebellopontine angle (CPA) neoplasms The concomitant use of warfarin and other anticoagulants A known metabolic disease such as Refsum disease Inherited bleeding disorders, such as hemophilia and Von Willebrand's disease and other bleeding disorders Abnormal international normalized ratio (INR), partial thromboplastin time (PTT), prothrombin time (PT) test results Corticosteroids Contraindications Lipid-lowering medications users, such as intestinal agents, statins,niacin and fibrates Lactation and Pregnancy Allergy to fish and fish oil
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 78
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
In this triple-blinded, randomized, placebo-controlled trial,we use of SAS statistical softwared to randomize the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principle investigator and other investigators,physicians, nurses, audiologists,pharmacist, data collectors, outcome assessors are blinded during study about kind of drug (steroid+plasebo or steroid+omega-3) that patients will take.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vice Chancellor in Research Affairs, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-07-04, 1397/04/13
Ethics committee reference number
IR.TUMS.VCR.REC.1397.237

Health conditions studied

1

Description of health condition studied
Sudden Sensorineural Hearing Loss
ICD-10 code
H91.20
ICD-10 code description
Sudden idiopathic hearing loss, unspecified ear

Primary outcomes

1

Description
Pure Tone Audiogram “PTA”
Timepoint
Before intervention and 10,30 days after intervention
Method of measurement
Clinical audiometer (AC33)

Secondary outcomes

1

Description
Speech Recognition Threshold “SRT”
Timepoint
Before intervention,10 days, and 30 days after intervention
Method of measurement
Speech Audiometry by clinical audiometer (AC 33)

2

Description
Word Recognition Score “WRS”
Timepoint
Before intervention,10 days, and 30 days after intervention
Method of measurement
Speech Audiometry by clinical audiometer (AC 33)

3

Description
Tympanogram
Timepoint
Before intervention,10 days, and 30 days after intervention
Method of measurement
Tympanometry by tympanometer

4

Description
Acoustic Reflex Threshold “ART”
Timepoint
Before intervention,10 days, and 30 days after intervention
Method of measurement
Tympanometry by tympanometer

Intervention groups

1

Description
Control group: Prednisolone 1 mg/kg orally once a day for 10 days to improve pure tone audiogram(PTA). If there is improvement, prednisolone continues for another 10-day program and if there is no improvement,we will change it to 8 mg Intratympanic dexamethasone injection for 6 injections every other day(standard treatment) + Placebo (glycerin oil 1000 mg/capsule) two times a day for one month.Zahravi Pharmaceutical Company will produce the placebo.
Category
Placebo

2

Description
Intervention group: Prednisolone 1 mg/kg orally once a day for 10 days to improve pure tone audiogram(PTA). If there is improvement,prednisolone continues for another 10-day program, and if there is no improvement we will change it to 8 mg Intratympanic dexamethasone injection for 6 injections every other day(standard treatment) + omega-3 (1000 mg/capsule) two times a day for one month.Zahravi Pharmaceutical Company will produce omega-3 capsules.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralam Hospital,Tehran University of Medical Siences
Full name of responsible person
Dr Benyamin Rahmaty
Street address
Amiralam Hospital,North Saadi St,District 12
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6671 2549
Email
b-rahmaty@razi.tums.ac.ir
Web page address
http://amiralam.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraeian
Street address
Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
resdeputy@tums.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
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Benyamin Rahmaty
Position
ENT Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amiralam hospital, Saadi St, Destrict12
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6671 2549
Email
b-rahmaty@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Keyvan Aghazadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Alam Hospital, North Saadi َSt, Enghelab Ave,Tehran
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6634 3352
Fax
Email
aghazadeh@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Benyamin Rahmaty
Position
ENT Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amiralam hospital, Saadi St, Destrict12
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6671 2549
Email
b-rahmaty@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
We will share all collected deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material),study protocol, statistical analysis Plan, informed consent form, clinical study report, analytic code.
When the data will become available and for how long
Beginning 3 months and ending 5 years following article publication.
To whom data/document is available
Researchers who provide a methodologically sound proposal.
Under which criteria data/document could be used
Proposals should be directed to Benyamin.rahmaty@gmail.com or B-rahmaty@razi.tums.ac.ir, To gain access, data requestors will need to sign a data access agreement.
From where data/document is obtainable
Applicants should make a formal request by email,then they will get data by email. Email address : B-rahmaty@razi.tums.ac.ir Benyamin.Rahmaty@gmail.com
What processes are involved for a request to access data/document
They can be accessed by email.
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