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Not yet recruiting NCT07334002

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

No phase Interventional Tinnitus Neural Therapy of Huneke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neural Therapy of Huneke, Betahistine 24 mg bid (Betaserc).
Who it may be relevant to
Registry conditions: Tinnitus, Neural Therapy of Huneke. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Single-blind, Controlled Trial to Evaluate the Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus

Overview

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.

Detailed 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.

Interventions

  • Procedure Neural Therapy of Huneke
    The aim for tinnitus and facial pain is to regulate the trigeminal system and autonomic balance. Concentration used: Lidocaine 0.5%. The auriculotemporal, infraorbital, zygomaticotemporal, and stellate regions were targeted. Puncture applications: 0.3-0.5 mL will be administered behind the ear, around the mastoid process, behind the tragus, and in the temporomandibular region. If necessary, the stellate ganglion area can be supplemented with regulation injections. Negative aspiration and as
  • Drug Betahistine 24 mg bid (Betaserc)
    Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.

Primary outcome measures

  • Turkish version of the Tinnitus Disability Questionnaire (THI) [Time frame: 3 months]
  • SF-12 (short form) [Time frame: 3 months]
  • Tinnitus severity according to VAS (visual analog scale) [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07334002 · 16.02.2021 / 3158

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗