Intratympanic dexamethasone plus melatonin versus melatonin in the treatment of acute idiopathic tinnitus

ISRCTN	ISRCTN39221710
DOI	https://doi.org/10.1186/ISRCTN39221710
Secondary identifying numbers	864/20.09.2013

Submission date: 26/11/2013
Registration date: 16/12/2013
Last edited: 16/12/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Felician Dorin Chirtes
Scientific

st Henri Barbusse nr 3-5
bloc Doina, ap 12
Cluj napoca
400616
Romania

Study information

Study design	Randomized interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact felicianchirtes@yahoo.com to request a patient information sheet
Scientific title	Intratympanic dexamethasone plus melatonin versus melatonin in the treatment of acute idiopathic tinnitus a randomized clinical trial
Study objectives	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(s)	Ethics Committee of the Iuliu Haţieganu University of Medicine and Pharmacy Cluj-Napoca, Romania, 22/11/2013, Ref : 917
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	02/12/2013
Completion date	01/03/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Male and female age ≥18 years 2. Willing to be assigned to any of the treatment groups 3. Informed consent
Key exclusion criteria	Patients with identifiable causes of acute tinnitus
Date of first enrolment	02/12/2013
Date of final enrolment	01/03/2014

Locations

Countries of recruitment

Romania

Study participating centre

st Henri Barbusse nr 3-5

Cluj napoca
400616
Romania

Sponsor information

Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca (Romania)
University/education

II-nd Department of Otolaryngology
Str. Republicii nr. 18
Cluj Napoca
3400
Romania

Website	http://www.umfcluj.ro/
"ROR"	https://ror.org/051h0cw83

Funders

Funder type

Other

Investigator initiated and funded (Romania)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan