NCT04026932

The Clinical Effects of Modified TRS Treatment

The Clinical Effects of Modified Tinnitus Relieving Sound Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinnitus, Subjective

Interventions

Type	Name	Description
OTHER	Listening to unmodified music	Listening to unmodified music for at least 2 hours a day
OTHER	Listening to modified tinnitus relieving sound	Listening to modified tinnitus relieving sound for at least 2 hours a day

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-01
• Completion: 2022-02-01
• First posted: 2019-07-19
• Last updated: 2019-07-19

Locations

1 site across 1 country: China