Personalized Music-Embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduce… (NCT07637708) | Clinical Trial Compass
CompletedNot Applicable
Personalized Music-Embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduces Tinnitus Severity
Chile25 participantsStarted 2024-10-01
Plain-language summary
This clinical trial evaluated a personalized music-embedded sound therapy for adults with chronic subjective tinnitus. Tinnitus is the perception of sound, such as ringing or buzzing, without an external source and can negatively affect quality of life.
Participants were randomly assigned to one of two groups. One group received personalized music-embedded desynchronization sound therapy, using tones selected according to each participant's tinnitus frequency and embedded in music. The comparison group received low-frequency sound stimulation embedded in music. Both interventions were designed to be similar for participants.
The main objective was to evaluate whether the personalized music-embedded sound therapy reduced tinnitus severity compared with low-frequency sound stimulation. Tinnitus severity was measured using the Tinnitus Handicap Inventory at baseline and during follow-up.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged 18 to 75 years.
Diagnosis of chronic subjective tinnitus lasting more than 6 months.
Non-pulsatile tinnitus.
Tonal tinnitus with an identifiable tinnitus frequency.
Unilateral or bilateral tinnitus.
Ability to understand the study procedures and provide written informed consent.
Ability to comply with the assigned sound therapy protocol and follow-up assessments.
Exclusion Criteria:
Pulsatile tinnitus.
Non-tonal tinnitus.
History of auditory hallucinations.
History of Ménière's disease.
History of other active middle or inner ear disease with neurological sequelae.
Current use of centrally acting medications that could interfere with tinnitus perception or auditory processing.
Severe hearing loss preventing adequate perception of the auditory stimuli.
Inability to complete the follow-up assessments.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.