Plain English Summary
Background and study aims
Intratympanic drug delivery (a surgical technique of delivering medication into the middle ear) results in a higher drug concentration and very low side effects. Intratympanic dexamethasone has been used for treating a wide range of inner ear diseases and oral melatonin works well in relieving idiopathic tinnitus (ringing in the ears).
The study aims to assess whether intratympanic dexamethasone in association with oral melatonin is better than oral melatonin alone in the treatment of acute idiopathic tinnitus.
Who can participate ?
Adult male and female patients suffering acute tinnitus with no apparent cause for it.
What does the study involve ?
Patients will be randomly allocated to one of two treatment groups. One group of patients with acute idiopathic tinnitus will be treated with oral melatonin alone and another group will receive oral melatonin and intratympanic dexamethasone. At the end of the study we shall compare the relief of tinnitus in each group.
What are the possible benefits and risks of participation ?
Participants in the intratympanic dexamethasone plus melatonin group may experience a faster relief of tinnitus. The side effects include complications of intratympanic drug delivery, mainly acute otitis media (ear infection), transitory vertigo (dizziness), persistent eardrum perforations and hearing loss.
Where is the study run from?
The study is conducted at Spitalul Clinic CF Cluj Napoca, Romania.
When is the study starting and how long is it expected to run for ?
The study will start in December 2013 and will run until March 2014.
Who is funding the study ?
The study is funded by the researcher.
Who is the main contact ?
Dr Chirtes Felician
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
864/20.09.2013
Study information
Scientific title
Intratympanic dexamethasone plus melatonin versus melatonin in the treatment of acute idiopathic tinnitus a randomized clinical trial
Acronym
Study hypothesis
We hypothesize that the association of intratympanic dexamethasone and oral melatonin will result in faster relief of tinnitus during the treatment of acute idiopathic tinnitus compared to oral melatonin alone.
Ethics approval
Ethics Committee of the Iuliu Haţieganu University of Medicine and Pharmacy Cluj-Napoca, Romania, 22/11/2013, Ref : 917
Study design
Randomized interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact felicianchirtes@yahoo.com to request a patient information sheet
Condition
Acute idiopathic tinnitus
Intervention
Patients are randomly allocated to one of two groups. In one group the patients will be given melatonin plus four intra-tympanic dexamethasone injections, one on each 7 consecutive initial days. The patients will be given 3 mg of melatonin, 1 tablet nightly 1 to 2 hours before bedtime for 8 weeks. In the other group, patients will get melatonin tablets and intra-tympanic isotonic sodium chloride solution following the above mentioned schedule.
Follow-up: 3 months
Intervention type
Drug
Phase
Not Applicable
Drug names
Melatonin, dexamethsaone
Primary outcome measure
Patients selected as eligible will complete specific questionnaires at the beginning of the study and 3 months after the beginning of the treatment. Improvement in tinnitus should be assessed using three outcome measures:
1. Tinnitus loudness score (on a 10-point scale, 10 being loudest)
2. Tinnitus awareness score (percentage of the time the subject is aware of tinnitus)
3. Tinnitus Handicap Inventory (THI)
According to previous stated criteria, we define improvement as a >10% reduction of tinnitus awareness score, >2-point reduction of tinnitus loudness score, and >20-point reduction in THI. Cure is defined as a reduction in tinnitus awareness score to 0%.
Secondary outcome measures
Side effects of intratympanic dexamethasone:
1. Acute otitis media
2. Persistent eardrum perforation
3. Vertigo
4. Hearing loss
Overall trial start date
02/12/2013
Overall trial end date
01/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female age ≥18 years
2. Willing to be assigned to any of the treatment groups
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Patients with identifiable causes of acute tinnitus
Recruitment start date
02/12/2013
Recruitment end date
01/03/2014
Locations
Countries of recruitment
Romania
Trial participating centre
st Henri Barbusse nr 3-5
Cluj napoca
400616
Romania
Sponsor information
Organisation
Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca (Romania)
Sponsor details
II-nd Department of Otolaryngology
Str. Republicii nr. 18
Cluj Napoca
3400
Romania
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Romania)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list