Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia

Last updated: May 29, 2026
Sponsor: Eye & ENT Hospital of Fudan University
Overall Status: Completed

Phase

N/A

Condition

Tinnitus

Insomnia

Treatment

Customized sound therapy

ACT for tinnitus

Clinical Study ID

NCT05963542
2023066-1
  • Ages 18-80
  • All Genders

Study Summary

Considering the lack of evidence on the effects of combining acceptance and commitment therapy (ACT) with customized sound therapy for tinnitus-related insomnia patients, investigators designed this single-blind, 5-months randomized, controlled trial with two parallel groups. One is the ACT + sound therapy group, and the other is the sound therapy group.

Eligibility Criteria

Inclusion

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 internetconnection to work with text material.

Exclusion

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 hearingloss).

  4. Severe mental illness.

  5. Undergoing other research that may affect tinnitus and sleep.

Study Design

Total Participants: 164
Treatment Group(s): 2
Primary Treatment: Customized sound therapy
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
March 29, 2026

Study Description

Insomnia is one of the most frequent and severe comorbidities in patients with tinnitus and is highly relevant for the perceived tinnitus severity. Both tinnitus and insomnia significantly affect the quality of life of patients and represent a huge burden to society. While interventions exist to alleviate tinnitus distress, they often do not address sleep disturbances in tinnitus patients. Patients affected by tinnitus and insomnia suffer from long-term functional and psychological problems. Sound therapy is widely used to treat tinnitus, often combined with education and counseling, and can effectively improve the quality of life. In addition, acceptance and commitment therapy (ACT) for tinnitus improves both tinnitus and sleep. However, there is a lack of evidence on the effects of combining ACT with sound therapy for tinnitus-related insomnia patients.

To fully characterize tinnitus patients, standardized measures of tinnitus and insomnia are essential. These measures include pure tone audiometry (PTA), acoustic immittance (AI), tinnitus pitch matching (PM) and loudness matching (LM), minimum masking level (MML), tinnitus handicap inventory (THI), insomnia severity index (ISI), and hospital anxiety and depression scale (HADS).

Investigators hypothesize that the combination of ACT and sound therapy will be superiority to sound therapy alone in reducing tinnitus distress.

Connect with a study center

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

    Shanghai, Shanghai Municipality 200031
    China

    Site Not Available

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