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Can online therapy and sound ease ringing ears?

NCT ID NCT05963542

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested whether combining online acceptance and commitment therapy (ACT) with customized sound therapy helps people with tinnitus and insomnia. 164 adults were split into two groups: one received both therapies, the other only sound therapy. The goal was to see if the combination reduces tinnitus-related distress and improves sleep better than sound therapy alone.

What this could mean

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

Active substance
acceptance and commitment therapy (ACT) and customized sound therapy
What this could lead to
If it works, this could offer a practical, at-home way to reduce tinnitus distress and improve sleep without medication.
What could go wrong
This is a single, completed trial with 164 participants. The results may not apply to everyone, and the benefits might be modest or not last long-term.

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

164 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2026

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 80 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: 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 8 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.

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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

Contacts and locations

Locations

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

    Shanghai, Shanghai Municipality, 200031, China

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