None listed
Conditions
Interventions
Medical Device : Experimental Group (Intervention Group)
? Name of Intervention
TD2 (Tinnitus Digital Treatment Device), a virtual reality–based multisensory cognitive behavioral therapy software.
? C
Sponsors
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants aged 19 years or older at the time of signing the written informed consent form. 2) Participants with chronic tinnitus persisting for 3 months or longer. 3) Participants with pure-tone audiometry results of 60 dB or less, based on the six-frequency pure-tone average air-conduction threshold. 4) Participants with a Tinnitus Handicap Inventory (THI) total score between 18 and 76, inclusive. 5) Participants who are currently taking medications related to subjective tinnitus and are able to maintain the same dosage and regimen for at least 2 weeks prior to enrollment and throughout the clinical trial participation period (6 weeks). 6) Participants who voluntarily agree to participate in this clinical trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Individuals diagnosed with objective tinnitus, such as pulsatile or muscular tinnitus. 2) Individuals whose tinnitus is determined to be caused by middle ear disease, inner ear inflammation, or retrocochlear pathology. 3) Individuals diagnosed, according to DSM-5-TR, with any of the following psychiatric disorders other than major depressive disorder: - Major or mild neurocognitive disorders due to primary neurodegenerative diseases (e.g., Alzheimer’s disease, frontotemporal degeneration, or Lewy body dementia) - Schizophrenia spectrum and other psychotic disorders - Bipolar and related disorders - Any other DSM-5-TR psychiatric disorder (excluding major depressive disorder within the Depressive Disorders category) 4) Pregnant or breastfeeding women. 5) Individuals who have participated in another clinical trial within 1 month prior to enrollment. 6)Any individual who, in the investigator’s judgment, is deemed unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the change in total THI (Tinnitus Handicap Inventory) score from baseline to Week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the change in total THI (Tinnitus Handicap Inventory) score from baseline to each assessment visit;Comparison of the change in THI (Tinnitus Handicap Inventory) subscale scores from baseline to each assessment visit;Comparison of the change in total TFI (Tinnitus Functional Index) score from baseline to each assessment visit;Comparison of the change in NRS (Numerical Rating Scale) scores for subjective tinnitus improvement (perceived loudness and discomfort level) from baseline to each assessment visit;Comparison of the change in total HADS (Hospital Anxiety and Depression Scale) score from baseline to each assessment visit;Comparison of the change in Electroencephalography spectral power indices by frequency band from baseline to the end of the study | — |
Countries
Korea, Republic of
Contacts
Public ContactJune Choi
Korea University Ansan Hospital
Outcome results
None listed