Skip to content

The role of the use of steroids intravenously, intratympanically or in combination in the treatment of idiopathic sudden sensorineural hearing loss.

The role of the use of steroids intravenously, intratympanically or in combination in the hearing rehabilitation of patients with idiopathic sudden sensorineural hearing loss. A prospective, randomized, blind, interventional, controlled clinical trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001032741
Enrollment
102
Registered
2013-09-17
Start date
2013-09-25
Completion date
2016-06-02
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study intends to enroll 75 patients who suffer from idiopathic sudden sensorineural hearing loss. These patients will be divided into three groups of 25 subjects each. Each group will be treated either with intravenous steroids or with intratympanic steroids or with the combination of intravenous and intratympanic steroids respectively. In order to assess the hearing outcomes, pure-tone hearing average and frequency-specific thresholds will be obtained on determined days during and after the completion of the treatment. Moreover the presence and the severity of tinnitus will be assessed with the use of the assessment form of the Tinnitus Research Group of Japan Audiological Society, 1993. The aim of this study is to compare the efficacy of the three above mentioned treatment modalities in patients who suffer from idiopathic sudden sensorineural hearing loss.

Interventions

The study group will include patients who suffer from idiopathic sudden sensorineural hearing loss and fulfil the inclusion criteria. After the randomization procedure, all these patients will be divided into three groups (group A, group B, group C) in order to receive different treatment modalities. The intervention in each group will be as follows: Group A-Arm1 (intravenous steroid use) The patients of this group will be admitted in the hospital and will receive prednisolone intravenously. Th

The study group will include patients who suffer from idiopathic sudden sensorineural hearing loss and fulfil the inclusion criteria. After the randomization procedure, all these patients will be divided into three groups (group A, group B, group C) in order to receive different treatment modalities. The intervention in each group will be as follows: Group A-Arm1 (intravenous steroid use) The patients of this group will be admitted in the hospital and will receive prednisolone intravenously. The dosage of prednisolone will be 1mg/kg of body weight once daily (in the morning) for 7 days, reduced to 0.5 mg/kg of body weight once daily (in the morning) for another 3 days. The patients will stay hospitalized for 10 days in total. After being discharged they will receive methylprednisolone orally. The dosage of methylprednisolone will be 32 mg daily for 4 days, reduced to 16 mg daily for another 3 days.. After that any treatment will be discontinued. Group B-Arm 2 (intratympanic steroid use) The patients of this group will not be admitted in the hospital. Instead of this, they will visit the Outpatient Clinics department on specific days in order to undergo intratympanic injections of methylprednisolone. The technique of intratympanic injection of methylprednisolone will be the following: 1 hour prior to the injection, every patient will receive orally 1 tablet that contains 500 mg of paracetamol and 1 tablet that contains 400 mg of paracetamol, 50 mg of codeine and 10 mg of caffeine. These will act as painkillers that will reduce the pain/discomfort caused by the intratympanic injection. The patient will be placed in the supine position with the head tilted 45 degrees towards the healthy ear. The solution of methylprednisolne will be placed in an insuline syringe. After that, this syringe is adapted to an 25 gauge spine needle. This needle is inserted into the middle ear through the posterior-inferior quadrant of the tympanic membrane. In this way, 0.3 to 0.5 ml of a solution that contains 62.5 mg/ml methylprednisolone are injected into the middle ear. The patient is advised to avoid swallowing and to stay in the same position for 30 min after the injection in order to allow the medication to be absorbed from the inner ear through the round window. The intratympanic injections will be performed on the following days: Day 1 (day of diagnosis), day 3, day 5, day 10. Group C-Arm 3 (combined steroid use) The patients of this group will be admitted in the hospital and will receive combined intravenous and intratympanic steroids as described above. During the 10 days of hospitalization each patient will receive intravenous prednisolone 1mg/kg of body weight once daily (in the morning) for 7 days, reduced to 0.5 mg/kg of body weight once daily (in the morning) for another 3 days. At the same time he/she will undergo intratympanic injection of a solution that contains 62.5 mg/ml of methylprednisolone on the days 1, 3, 5 and 10. After the discharge the patients will receive treatment orally as described above (group A). Please note that in case of complete recovery prior to the completion of the treatment, all steroids will be discontinued in all three groups. Moreover, in order to monitor the adhererence to the oral steroid treatment, each patient will be given a special form. On this form he/she will have to note down the number of the tablets of methylprednisolone 8mg that he/she will take on each one of the determined days. Moreover, he/she will have to note down the time at which each tablet was taken. This form will be returned by each patient and assessed by the investigator on day 30. The adherence to the intravenous and intratympanic treatment will be ensured by the investigator and the nursing stuff that will perform the interventions.

Sponsors

Medical School of Aristotle University of Thessaloniki
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Idiopathic sudden sensorineural hearing loss

Exclusion criteria

1) Patients that seeked medical assistance after more than 14 days from the initiation of symptoms. 2) Patients with bilateral sudden sensorineural hearing loss. 3) Patients that have already received treatment for this reason. 4) Patients with known causes of sudden sensorineural hearing loss such as Meniere disease, autoimmune disease, syphilis, trauma, ototoxic agents. 5) MRI of brain and cerebellopontine angle indicative of acoustic neuroma or other retrocochlear lesion (eg demyelinating disease) that can cause sudden sensorineural hearing loss. 6) Pregnancy or breast feeding. 7) Patients younger than 18 years old. 8) History of psychic disorders. 9) History of glaucoma. 10) Active inflammation of the affected ear. 11) Tympanic membrane perforation at the side of the disease. 12) Diabetes mellitus (glucose level higher than 180 mg/ml at baseline) 13) Hypertension (systolic blood pressure higher than 180 mmHg or diastolic blood pressure higher than 110 mmHg at the baseline). 14) Contraindications for the use of steroids (peptic ulcer, osteoporosis, immune suppression).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026