Chronic tinnitus (ICD-10 Code : H93.1 (Tinnitus) Specific Details: Subjective tinnitus lasting for more than 6 months. The study focuses on patients with at least mild severity (Tinnitus Handicap Inventory score). Tinnitus
Conditions
Interventions
Participants receive standard counseling and use the ReSound Tinnitus Relief smartphone application. The application provides nature sounds or white noise through smartphone speakers or headphones. Pa
Experimental Behavioral,Active Comparator Behavioral
Smartphone application-based sound therapy plus standard counseling,Standard counseling
Sponsors
Vajira hospital, Navamindradhiraj university
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-60 years. 2.Chronic tinnitus for more than 6 months, unilateral or bilateral. 3.Tinnitus affecting daily functioning, with a Tinnitus Handicap Inventory (THI) score of 18 or more (at least mild severity). 4.Tinnitus not attributable to other otologic or neurologic disorders such as acoustic neuroma, Menieres disease, or other known neurologic conditions. 5.Ownership of a personal smartphone capable of installing and using the study application (Android or iOS). 6.Hearing thresholds within normal to moderate hearing loss range (less than or equal to 55 dB HL pure-tone average at 500, 1000, 2000, and 4000 Hz) in the tinnitus-affected ear, based on pure-tone audiometry.
Exclusion criteria
Exclusion criteria: 1.Patients with objective tinnitus or pulsatile tinnitus. 2.Patients with active middle ear infection or external ear canal pathology. 3.Patients who cannot use a smartphone or the ReSound Tinnitus Relief application. 4.Patients currently using hearing aids. 5.Patients with moderate-to-severe hearing loss (greater than 55 dB HL). 6.Patients with a history of ear surgery within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Tinnitus Handicap Inventory THI Thai version score Baseline, 1 month, 3 months, and 6 months Total score on a scale of 0 to 100 where higher scores indicate greater handicap | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale VAS for Loudness and Annoyance Baseline, 1 month, 3 months, and 6 months Score on a 0 to 10 centimeter scale where 0 is no sound and 10 is the loudest imaginable,Hospital Anxiety and Depression Scale HADS Baseline, 1 month, 3 months, and 6 months Total score and subscale scores for anxiety and depression ranging from 0 to 21,Patient Global Impression of Change PGIC 1 month, 3 months, and 6 months A 7 point Likert scale ranging from 1 very much improved to 7 very much worse | — |
Countries
Thailand
Contacts
Public ContactArtorn Supan
Otolaryngology department, Vajira hospital
Outcome results
None listed