The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus

Sisli Hamidiye Etfal Training and Research Hospital

Status: Not yet enrolling

Conditions: Neural Therapy of Huneke; Tinnitus

Treatments: Drug: Betahistine 24 mg bid (Betaserc); Procedure: Neural Therapy of Huneke

Study type: Interventional

Funder types: Other

Identifiers

NCT07334002

16.02.2021 / 3158

Details and patient eligibility

About

A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus.

The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.

Full description

All patients with normal otologic examinations and a type A tympanogram will be included in the study. Those who meet the exclusion criteria will not be included in the study, and patients will be randomized. Subsequently, the groups will be divided into two groups: those who will receive only medical treatment and those who will receive neural therapy in addition to medical treatment. Patients will be administered tinnitus severity questionnaires based on the SF-12 (short form) and the VAS (visual analog scale), the Turkish adaptation of the Tinnitus Disability Inventory (THI). The same questionnaires will be administered at their follow-up visits three months later.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a type A tympanogram in the tympanogram of all cases with normal otological examinations (air-bone gap should not be observed in any case).

Exclusion criteria

• Patients with a disease that may cause objective tinnitus,

  • Otosclerosis,
  • Chronic otitis media,
  • Acoustic tumor,
  • Meniere's disease,
  • History of ear surgery or head trauma, and those with neuropsychiatric diseases.

Also:

• Patients who have had ear surgery,
• Permanent hearing loss (total),
• Severe cardiovascular system failure, uncontrolled arrhythmia,
• Severe renal failure, or liver failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Treatment Group

Experimental group

Treatment:

Procedure: Neural Therapy of Huneke

Control Group

Active Comparator group

Treatment:

Drug: Betahistine 24 mg bid (Betaserc)