Subjective Tinnitus, Tinnitus
Conditions
Keywords
tinnitus, vagus nerve stimulation, sound stimulation, auricular stimulation, medical device
Brief summary
This study was conducted to evaluate the efficacy and safety of Soricle, a medical device combining transcutaneous vagus nerve stimulation and sound stimulation, in patients with subjective tinnitus. Participants were randomly assigned to either the active treatment group or a sham control group in a double-blind manner. The device was used daily for 8 weeks. The primary objective was to assess the improvement in tinnitus symptoms, and safety was evaluated throughout the study period.
Detailed description
This was a prospective, single-center, randomized, double-blind, sham-controlled exploratory clinical trial designed to evaluate the efficacy and safety of Soricle, a Class III medical device combining transcutaneous vagus nerve stimulation (tVNS) and sound stimulation, for the treatment of subjective tinnitus. Participants diagnosed with subjective tinnitus were randomly assigned in a 1:1 ratio to either the active treatment group or the sham control group. The investigational device was applied daily for 8 weeks. The primary objective of the study was to evaluate the improvement in tinnitus symptoms, and secondary objectives included additional efficacy assessments and safety evaluations. Safety was monitored throughout the study, including the assessment of adverse events. The study was conducted in accordance with ICH-GCP guidelines and was approved by the Institutional Review Board. All participants provided written informed consent prior to participation.
Interventions
DEVICESham Device
A sham device identical in appearance to the active device but without delivering therapeutic stimulation.
DEVICEtVNS Device
A medical device delivering transcutaneous vagus nerve stimulation (tVNS) via auricular stimulation.
DEVICEtVNS + Sound Stimulation Device
A medical device delivering combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation.
Sponsors
Neurive Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study was conducted in a double-blind manner. Participants, investigators, care providers, and outcome assessors were blinded to group assignments. The active device and sham device were identical in appearance to maintain blinding.
Intervention model description
Participants were randomized in a 1:1 ratio to either the active treatment group or the sham control group in a parallel design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older * Patients with subjective tinnitus * Able to understand and provide informed consent * Willing to comply with study procedures
Exclusion criteria
* Objective tinnitus * Severe hearing loss requiring immediate treatment * History of neurological or psychiatric disorders that may affect study outcomes * Use of other tinnitus treatments during the study period * Any condition that, in the investigator's judgment, may interfere with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Handicap Inventory (THI) Score | 8 weeks | The change in Tinnitus Handicap Inventory (THI) score from baseline to 8 weeks was assessed to evaluate the effectiveness of the intervention. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJaegu Cho
Korea University Guro Hospital
Outcome results
None listed