Efficacy and Safety of Soriclear, Congnitive Behavioral Therapy, Tones Stimulator in patients with Subjective Tinnitus: Prospective, Multi-center

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011314

Enrollment

292

Registered

2025-12-11

Start date

2024-01-18

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Participants in the SoriClear group are instructed to engage in SoriClear’s personalized internet-based cognitive behavioral therapy (iCBT), complete thought records, and receive soun

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or female participants aged 19 years or older 2) Individuals with confirmed chronic tinnitus lasting for more than 3 months 3) Individuals with pure-tone air conduction hearing thresholds of 60 dB HL or lower (based on the 6-division method) 4) Individuals with a Tinnitus Handicap Inventory (THI) score of 18 or higher 5) Individuals capable of using the internet and mobile applications 6) Individuals who have understood the nature of the clinical trial and voluntarily signed the informed consent form

Exclusion criteria

Exclusion criteria: 1) Individuals diagnosed with objective tinnitus (e.g., pulsatile or muscular tinnitus) 2) Individuals whose tinnitus is confirmed to be caused by middle ear infection, inner ear infection, or Eustachian tube disorder 3) Individuals diagnosed with any other primary neurodegenerative dementia, schizophrenia, or bipolar disorder, or any other DSM-V Axis I disorder, excluding depression 4) Individuals deemed unsuitable for participation in this clinical trial by the principal investigator 5) Individuals currently participating in another clinical trial or who have participated in another clinical trial within one month prior to the screening date

Design outcomes

Primary

Measure	Time frame
Total Tinnitus Handicap Inventory score change	—

Secondary

Measure	Time frame
Total Tinnitus Functional Index score change;Change in tinnitus pitch and loudness matching;Change in Visual analog scale (Emotional Distress);Change in Visual analog scale (Cognitive Distress);Satisfaction questionnaire score	—

Countries

Korea, Republic of

Contacts

Public ContactSo-Young Park

The Catholic University of Korea, Seoul St. Mary's Hospital

miffy8624 @naver.com+82-2-2258-6210

Outcome results