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A Multicenter Clinical Research on the Efficacy of Tinnitus Sound Therapy

A Multicenter Clinical Research on the Efficacy of Tinnitus Sound Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039007
Enrollment
Unknown
Registered
2020-10-13
Start date
2021-05-14
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Tinnitus

Interventions

Modified tinnitus relieving sound (MTRS):Listening to the treatment sound at least 2 hours a day in total
Modified energy enriched sound:Listening to the treatment sound at least 2 hours a day in total
Unmodified music and narrow band noise:Listening to the treatment sound at least 2 hours a day in total
Unmodified music:Listening to the treatment sound at least 2 hours a day in total

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged between 18 to 80 years old; 2. Diagnosed with subjective tinnitus; 3. Chronic tinnitus: tinnitus course >= 3 months; 4. Be able to understand and communicate with Mandarin; 5. The average pure tone threshold (0.5, 1, 2kHz) <= 55dB HL of the worse ear; 6. Subjects are able to understand the purpose of the study, and be willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pulsatile tinnitus and objective tinnitus; 2. Individuals with major health issues that affect or prevent participation in the experiment or follow-up; 3. Conditions requiring other medical interventions first, such as infections, tumors, otosclerosis, Ménière's disease, or acute phase of sudden deafness; 4. Individuals with severe hyperacusis or serious mental illnesses such as severe anxiety or depression; 5. Currently participating in other research projects that may affect tinnitus; 6. Subjects deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Tinnitus Handicapped Inventory (THI);

Secondary

MeasureTime frame
Hospital Anxiety and Distress Scale (HADS);Athens Insomnia Scale (AIS);Visual Analogue Scale (VAS) for tinnitus;Tinnitus loudness matched by sensation level (LM, SL);

Countries

China

Contacts

Public ContactLi Huawei

Eye & ENT Hospital of Fudan University

hwli@shmu.edu.cn+86 189 1778 5659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026