Not Yet Recruiting

NCT Number: NCT07334002

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neural Therapy of Huneke Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neural Therapy of Huneke

Procedure

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 aseptic technique will be applied before each application.

Transient mild dizziness or local redness may occur after application.

To avoid the risk of systemic toxicity, the total dose should generally not exceed a maximum of 200 mg of lidocaine.

Betahistine 24 mg bid (Betaserc)

Drug

Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jülide Öncü Alptekin, Professor Doctor, MD

CONTACT

[email protected]

+90507 231 6817

Roza Jizel Dağdelen, MD

CONTACT

[email protected]

+90 212 373 50 00

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 12, 2026
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting