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The efficacy of intratympanic injection of nanogel dexamethasone in Sudden Sensorineural Hearing Loss (SSNHL) treatment,

The effectiveness of intratympanic injection of nanogel dexamethasone versus non-nanogel dexamethasone in treatment of patients with Sudden Sensorineural Hearing Loss (SSNHL), a double blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220307054210N1
Enrollment
90
Registered
2023-04-05
Start date
2022-03-26
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Sudden Sensorineural Hearing Loss. Sudden idiopathic hearing loss, unspecified ear

Interventions

Intervention 1: Control group: Patients in this group will receive oral prednisolone at a dose of 1 mg per kg to a maximum of 60 mg daily for 14 days. Intervention 2: Intervention group: for patients
If unsuccessful, re-injection will be given with less dexamethasone. This operation will be performed 4 times during an 8-day period every other day. Each patient will also receive oral prednisolone a

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: One-way SSNHL at 30 dB at three consecutive frequencies generated in 72 hours or less The time period from the time of hearing loss until the patient is admitted to the hospital for the procedure is less than or equal to 45 days

Exclusion criteria

Exclusion criteria: Evidence of otitis media on examination and history Known history of ear anomaleis Evidence of retrocuclear disease, history of meniere's disease history of acoustic trauma history of immunodeficiency history of sudden sensory neural hearing loss with other known couses history of heart disease

Design outcomes

Primary

MeasureTime frame
Hearing level. Timepoint: Measurement of the patient's hearing level at the beginning of the study (before the intervention) and 2 weeks after and 2 months after the start of the treatment period. Method of measurement: The hearing level was measured with audiometric criteria (PTA and srt) using an audiogram.;Vertigo. Timepoint: Vertigo was examined before the start of treatment and 2 weeks and 2 months after the start of treatment. Method of measurement: Dizziness was investigated using a questionnaire.;Tinnitus. Timepoint: tinnitus was examined before the start of treatment and 2 weeks and 2 months after the start of treatment. Method of measurement: tinnitus was investigated using a questionnaire.

Secondary

MeasureTime frame
SRT :(speech recognition threshold). Timepoint: before intervention and 2 and 4 weeks after intervention. Method of measurement: audiometry.;PTA:( pure tone audiometry). Timepoint: before intervention and 2 and 4 weeks after intervention. Method of measurement: audiometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshteh Fazlinezhad

Kerman University of Medical Sciences

ffazlinejad@kmu.ac.ir+98 56 3246 1031

Outcome results

None listed

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