The Clinical Effects of Modified Tinnitus Relieving Sound Treatment
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Tinnitus Handicapped Inventory (THI)
Study Overview
Brief Summary
Objective Tinnitus is one of the most common acoustic disorders by affecting 5-43% people around the world, and tinnitus is harmful to social and individuals, inducing to annoyance, irritability, anxiety, depression, insomnia and concentration difficulties. Many efforts have been made to help tinnitus suffers, however, the curative means are still in absence. This study aims to introduce a novel sound therapy for tinnitus and to evaluate the efficacy of modified tinnitus relieving sound treatment in comparison with unmodified music which served as a control.
Methods and analysis A randomized, triple-blinded, controlled, clinical trial will be carried out. 68 patients with subjective tinnitus will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Distress Scale (HADS), and visual analogue scale (VAS) for tinnitus; the secondary outcome measures will be Athens Insomnia Scale (AIS), tinnitus loudness matched by sensation level (LM, SL), and minimum masking level (MML). Assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. The sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged between 18 to 80 years old;
- •Diagnosed with subjective tinnitus;
- •Chronic tinnitus: tinnitus course ≥3 months;
- •Be able to understand and communicate with Mandarin；
- •The average pure tone threshold (0.5, 1, 2kHz) ≤ 55dB HL of the worse ear;
- •Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent.
Exclusion Criteria
- •Pulsatile tinnitus and objective tinnitus；
- •Having significant health issues that affect or prevent participation or continue with the follow-up;
- •Diseases requiring other medical intervention first (eg, infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss);
- •People with severe hyperacusis, severe anxiety, depression and other psychiatric disorders；
- •Currently participating in other research projects that may affect tinnitus；
- •Subjects who are not considered suitable for this clinical trial by the researchers.
Outcomes
Primary Outcomes
Tinnitus Handicapped Inventory (THI)
Time Frame: 12 months from baseline
THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.
Hospital Anxiety and Distress Scale (HADS)
Time Frame: 12 months from baseline
HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).
Visual Analogue Scale (VAS) for tinnitus
Time Frame: 12 months from baseline
Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.
Secondary Outcomes
- Athens Insomnia Scale (AIS)(12 months from baseline)
- tinnitus loudness matched by sensation level (LM, SL)(12 months from baseline)
- minimum masking level (MML)(12 months from baseline)