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Could fixing sleep silence the ringing? a digital therapy trial aims to find out

NCT ID NCT07769515

Symptom relief Sponsor: Eye & ENT Hospital of Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether an 8-week internet-based cognitive behavioral therapy for insomnia (CBT-I) can reduce the distress caused by tinnitus compared with standard patient education. About 168 adults with chronic tinnitus and poor sleep will be randomly assigned to one of the two online programs. The main goal is to see if CBT-I improves tinnitus-related handicap scores after two months, with secondary checks on sleep quality, mood, and tinnitus loudness over five months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Internet-based cognitive behavioral therapy for insomnia (CBT-I)
What this could lead to
If effective, this online therapy could offer a practical, drug-free way to reduce tinnitus-related distress and improve sleep in people with both conditions.
What could go wrong
The trial is relatively small and the therapy may not work for everyone. Benefits could be modest, and some people may find the online format less engaging than in-person care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged between 18 and 65 years; * Diagnosis of chronic subjective tinnitus persisting for at least 6 months; * A score of 38 or higher on the Tinnitus Handicap Inventory (THI); * An Insomnia Severity Index (ISI) score of 8 or higher; * Ability to understand the study procedures and provide informed consent; * Proficiency in reading and writing Chinese; * Access to a smartphone for participation in the digital intervention. Exclusion Criteria: * Objective or pulsatile tinnitus; * Specific otologic conditions requiring immediate medical treatment, such as sudden sensorineural hearing loss; * Diagnosed organic sleep disorders, such as obstructive sleep apnea; * Serious psychiatric disorders, including schizophrenia; * Concurrent enrollment in another clinical trial targeting tinnitus or insomnia.

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Conditions

The condition(s) this trial relates to.

insomnia tinnitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Tinnitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department

    Shanghai, Shanghai Municipality, 200031, China

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