Protocol summary
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Study aim
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Determining the Effect of Selenium Supplementation on Improving the Symptoms of Idiopathic Tinnitus & Introducing the Necessary Supplement to Improve the Symptoms of the Disease
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Design
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A phase 2 clinical trial on 60patients,with a control group,parallel groups, double-blind,randomized design.For simple randomization random.org website was used.
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Settings and conduct
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In this study, tinnitus patients who refer to RafidehHospital, Asma Comprehensive Center & Hearing Clinics & meet the inclusion criteria are selected.The patients will be randomly divided into 2Gp (generally sample size: 60).The intervention group will take 1Se pill daily & the control Gp will take 1placebo pill daily for 2months. Also, the therapist & the patient will be blinded to the type of medicine received. After 2months of the treatment period, the tinnitus annoyance index will be done by the THI questionnaire, psychoacoustic evaluation regarding the severity of tinnitus & its annoyance, as well as an audiogram examination to determine the hearing level of the patient.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Tinnitus with unknown cause, Having normal hearing or mild to severe hearing loss & having a specific age range
Exclusion criteria: Use of ACTS, pregnancy, observing any unforeseen complications, simultaneous receipt of drug treatment, history of otological & neurological diseases, breastfeeding
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Intervention groups
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In this study, patients with idiopathic tinnitus will be randomly divided into 2 gps: Gp1(30 people) will receive a 200 mcg Se supplement daily in the form of a pill & gp2 (30 people) will receive 1placebo orally every day with the same frequency of dose & the duration of treatment will be 2 months.
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Main outcome variables
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Tinnitus annoyingness index; psychoacoustic evaluation (determining the intensity of tinnitus and its annoyingness);determining the hearing level of the ear
General information
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Reason for update
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In order to standardize the patient diagnosis process and give more accurate results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160813029327N24
Registration date:
2024-09-20, 1403/06/30
Registration timing:
prospective
Last update:
2024-12-13, 1403/09/23
Update count:
1
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Registration date
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2024-09-20, 1403/06/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-09-22, 1403/07/01
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Expected recruitment end date
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2025-05-22, 1404/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of selenium in idiopathic tinnitus
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Public title
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The effect of Selenium on Idiopathic Tinnitus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having tinnitus that does not have specific pathological examinations.
Having normal hearing or Suffering from degrees of mild to severe hearing loss in the frequency range of 250-8000 Hz
Exclusion criteria:
Taking anticoagulant drugs
Pregnancy or intention to become pregnant
Not being in a good general mood
Observing any unforeseen complications
Lack of cooperation in psychoacoustic assessments of tinnitus
Receiving concomitant medical treatment or other tinnitus rehabilitation
History of Otological and Neurological Diseases
Breastfeeding
Presence of pulsating tinnitus
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random number table: 2 groups of 30 patients were created by using a simple randomization method through the website www.random.org and based on the Random Sequence Generator. To hide the random allocation, the method of opaque sealed envelopes with a random sequence was used. Patients were divided into one of two groups receiving selenium or receiving placebo based on the sequence of referrals.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is a double-blind, placebo-controlled study; So that in this study, both the research subject and the therapist are unaware of the patient's medication. Medicines are delivered to the patient in uniform packages marked with a unique code by a third person, and the information about the type of medicine cannot be seen by the therapist.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-06-18, 1403/03/29
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Ethics committee reference number
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IR.IAU.PS.REC.1403.132
Health conditions studied
1
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Description of health condition studied
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Tinnitus
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ICD-10 code
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H93.1
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ICD-10 code description
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Tinnitus
Primary outcomes
1
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Description
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Tinnitus annoyance index
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Timepoint
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At the beginning of the study (before the intervention) and 60 days after starting the treatment
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Method of measurement
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Tinnitus Handicap Inventory (THI) questionnaire
Secondary outcomes
1
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Description
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Psychoacoustic assessments of tinnitus
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Timepoint
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At the beginning of the study (before the intervention) and 60 days after starting the treatment
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Method of measurement
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Determination of perceived loudness of tinnitus by the patient through LMT(Loudness Matching of Tinnitus), PMT(Pitch Matching of Tinnitus), MML(Minimal Masking Level)
2
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Description
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Hearing threshold
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Timepoint
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At the beginning of the study (before the intervention) and 60 days after starting the treatment
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Method of measurement
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Audiogram chart or ear tape
Intervention groups
1
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Description
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Intervention group: For people who met the criteria for entering the research, they will receive a Selenium supplement in the form of 200 microgram tablet every day for two months - Selenium Health Burst - Porateb Company.
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Category
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Treatment - Drugs
2
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Description
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Control group: In people who met the criteria for entering the research, they will receive a placebo in the form of oral tablets every day for two months.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Patients' Demographic Data,Scores obtained from tinnitus performance questionnaire and hearing threshold
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When the data will become available and for how long
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One year after printing the results and publishing the article
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To whom data/document is available
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Academic persons
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Under which criteria data/document could be used
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Users should refer to the article
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From where data/document is obtainable
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By sending an email to the corresponding author
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What processes are involved for a request to access data/document
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By sending an email to the corresponding author
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Comments
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