Intratympanic dexamethasone plus melatonin versus melatonin in the treatment of acute idiopathic tinnitus
| ISRCTN | ISRCTN39221710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39221710 |
| Protocol serial number | 864/20.09.2013 |
| Sponsor | Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca (Romania) |
| Funder | Investigator initiated and funded (Romania) |
- 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
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
Scientific
st Henri Barbusse nr 3-5
bloc Doina, ap 12
Cluj napoca
400616
Romania
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Melatonin, dexamethsaone |
| Primary outcome measure(s) |
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: |
| Key secondary outcome measure(s) |
Side effects of intratympanic dexamethasone: |
| Completion date | 01/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
400616
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
