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

Intratympanic dexamethasone plus melatonin versus melatonin in the treatment of acute idiopathic tinnitus ? a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39221710

Enrollment

Registered

2013-12-16

Start date

2013-12-02

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute idiopathic tinnitus Ear, Nose and Throat Tinnitus

Interventions

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 p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female age =18 years 2. Willing to be assigned to any of the treatment groups 3. Informed consent

Exclusion criteria

Exclusion criteria: Patients with identifiable causes of acute tinnitus

Design outcomes

Primary

Measure	Time frame
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%.	—

Measure

Time frame

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

Measure	Time frame
Side effects of intratympanic dexamethasone: 1. Acute otitis media 2. Persistent eardrum perforation 3. Vertigo 4. Hearing loss	—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026