Condition category
Ear, Nose and Throat
Date applied
26/11/2013
Date assigned
16/12/2013
Last edited
16/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Felician Dorin Chirtes

ORCID ID

Contact details

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

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 measures

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

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

http://www.umfcluj.ro/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes