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Search / Trial NCT05963542

Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Jul 25, 2023

Trial Information

Current as of September 11, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of combining two types of therapy—Acceptance and Commitment Therapy (ACT) and customized sound therapy—on people who have tinnitus (a ringing or buzzing in the ears) and insomnia (trouble sleeping). The goal is to see if this combination can help improve the symptoms of tinnitus and help patients sleep better. The trial is open to adults between the ages of 18 and 80 who have experienced tinnitus for at least three months and have certain scores on specific questionnaires that indicate their level of distress from tinnitus and difficulty sleeping.

Participants in this study will be randomly assigned to one of two groups: one will receive both ACT and sound therapy, while the other will receive just sound therapy. The study will last for six months, and participants will be asked to use their smartphones to access the therapy materials. It’s important to note that those with specific types of tinnitus or other medical conditions that require treatment first won't be eligible to join. This trial aims to provide more evidence on how these therapies can work together to support individuals struggling with tinnitus and insomnia.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Adults aged between 18 and 80 years old.
  • 2. Experiencing subjective tinnitus for at least 3 months.
  • 3. A score of 38 or more on THI.
  • 4. A score of 15 or more on ISI.
  • 5. 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
  • 6. Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material.
  • Exclusion Criteria:
  • 1. Pulsatile tinnitus and objective tinnitus.
  • 2. Organic sleep disorders.
  • 3. Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss).
  • 4. Severe mental illness.
  • 5. Undergoing other research that may affect tinnitus and sleep.

About Eye & Ent Hospital Of Fudan University

The Eye & ENT Hospital of Fudan University is a leading clinical research institution dedicated to advancing the fields of ophthalmology and otolaryngology. With a commitment to innovative medical practices and patient-centered care, the hospital integrates cutting-edge research with clinical expertise to conduct comprehensive clinical trials. Leveraging a multidisciplinary approach, the institution aims to enhance treatment modalities and improve patient outcomes through rigorous scientific investigation and collaboration with academic and industry partners. Its state-of-the-art facilities and experienced team of professionals position the Eye & ENT Hospital of Fudan University as a pivotal contributor to medical advancements in eye and ear, nose, and throat health.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Huawei Li

Principal Investigator

Eye and ENT Hospital of Fudan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported