Combining online therapy and sound therapy for tinnitus and insomnia
SoundMind Trial: a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus
This study is testing if combining online therapy with sound therapy can help people with tinnitus sleep better and feel less distressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05963542 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining acceptance and commitment therapy (ACT) with customized sound therapy for patients suffering from tinnitus-related insomnia. It is a single-blind, randomized, controlled trial lasting six months, with participants divided into two groups: one receiving both ACT and sound therapy, and the other receiving only sound therapy. The study aims to assess the impact of this combined approach on reducing tinnitus distress and improving sleep quality, utilizing standardized measures for evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have experienced subjective tinnitus for at least three months and have significant insomnia.
Not a fit: Patients with pulsatile or objective tinnitus, organic sleep disorders, or severe mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from both tinnitus and insomnia.
How similar studies have performed: While sound therapy is commonly used for tinnitus, the combination with ACT is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai
- Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Huawei Li — Eye and ENT Hospital of Fudan University
- Study coordinator: Shan Sun
- Email: sunshine7896@126.com
- Phone: +86-021-64377134-2033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.