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A randomized controlled trial of sound therapy combined with cognitive behavioral therapy for subjective idiopathic tinnitus

A randomized controlled trial of sound therapy combined with cognitive behavioral therapy for subjective idiopathic tinnitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110888
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

tinnitus

Interventions

Tangential Filtered Acoustic Therapy Combined with Cognitive Behavioural Therapy Group:TMNMT combined with CBT
Cognitive Behavioural Therapy Group:CBT

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. subjective idiopathic tinnitus as the main complaint; 2. tinnitus duration of >= 6 months; 3. THI score >=38 and <=76; 4.0.25kHz to 8kHz hearing thresholds at all frequencies <=70dB HL; 5. Age 18 years (inclusive) to 70 years (inclusive).

Exclusion criteria

Exclusion criteria: 1. Presence of diseases of the outer or middle ear (e.g. otitis media, otosclerosis, etc.); 2. Presence of diseases known to cause tinnitus (e.g., acoustic neuroma, endolymphatic hydrops, etc.); 3. Presence of severe central nervous system or psychiatric disorders; 4. Tinnitus frequency > 8kHz; 5. Undergoing sound masking therapy; 6. Wearing a hearing aid; 7. Presence of contraindications to MRI or MEG examination, including but not limited to implantation of metal devices in the body (e.g. pacemaker, cochlear implant, etc.), severe claustrophobia, inability to lie down or remain still.

Design outcomes

Primary

MeasureTime frame
Tinnitus Disorder Scale Score Reduction;

Secondary

MeasureTime frame
THI scores and grades;Tinnitus matching loudness;magnetoencephalography signal;

Countries

China

Contacts

Public ContactYun Li

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

liyuncmm@126.com+86 139 1730 5407

Outcome results

None listed

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