AI doctor talks tinnitus away in landmark trial
NCT ID NCT07558837
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a conversational AI system called Fudan Tinnitus Doctor (FTD) for adults with chronic tinnitus. About 256 participants will use either the AI chatbot or a standard digital education program for 30 days. Researchers will measure changes in tinnitus severity, sleep quality, anxiety, and depression to see if the AI provides extra relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 256 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of subjective tinnitus confirmed by a qualified investigator. 2. Tinnitus duration ≥ 3 month prior to screening. 3. THI score of ≥ 18 4. Aged between 18 and 70 years 5. The ability to use a smartphone: Both groups will receive therapeutic support and disease management primarily through a mobile application or web-based platform. This requires functional ability to operate the provided software and willingness to engage with the digital intervention protocol. 6. Perceptibility: Tinnitus is present and recognizable by the participant under ordinary daily conditions (not only in quiet environments). 7. Compliance and consent: Participant is assessed by the Investigator as able to understand study procedures, voluntarily agrees to participate, is willing to comply with all trial-related requirements, and provides signed informed consent prior to performance of any protocol-specified procedure. Exclusion Criteria: 1. Acute-phase tinnitus (duration \< 3 month or tinnitus secondary to acute otologic events). 2. Pulsatile or objective tinnitus. 3. Unstable symptoms: Fluctuating tinnitus loudness at screening or baseline. 4. Psychiatric contraindication: History or current presence of severe psychiatric disorders (e.g., major depressive disorder with recent suicidality, schizophrenia) that, in the opinion of the Investigator, may interfere with study participation or data validity. 5. Testing limitations: Inability to adequately complete tinnitus testing procedures or comply with study assessments. 6. Prior therapy exposure: Previous history of sound therapy specifically for tinnitus management. 7. Concurrent treatments: Ongoing psychotherapy for conditions such as anxiety or depression, or any other psychological treatment that may interfere with the study endpoints. 8. Concurrent trial participation: Active participation in another interventional research study that, in the opinion of the Investigator, could affect tinnitus symptoms or interact with study procedures. 9. Investigator judgment: Any condition (medical, surgical, psychiatric, or social) or factor which, in the Investigator's judgment, renders the subject unsuitable for participation, places the patient at higher risk, or may interfere with compliance or scientific validity of the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
Shanghai, 200031, China
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Other studies related to the condition(s) this trial covers.
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