Tinnitus, Subjective Clinical Trial
Official title:
The Clinical Effects of Modified Tinnitus Relieving Sound Treatment
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.
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