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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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, 6-months randomized, controlled trial with two parallel groups. One is the ACT + sound therapy group, and the other is the sound therapy group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Somatic Tracking for Tinnitus

NCT06895824

Tinnitus

RECRUITING NA

Internet-delivered Psychological Interventions for Tinnitus

NCT05705323

Tinnitus Distress, Emotional Depression, Anxiety +1 more

COMPLETED NA

Mindfulness Meditation for Insomnia

NCT06972303

Sleep Initiation and Maintenance Disorders Insomnia Insomnia Chronic +2 more

RECRUITING PHASE1/PHASE2

Mindfulness-based Therapy in Chronic Tinnitus

NCT01540357

Chronic Tinnitus

COMPLETED NA

A Comparison of the Benefits of Mindfulness Based Cognitive Therapy, Relaxation Therapy and a Waiting List Control in the Management of Distress in Chronic Tinnitus Patients

NCT02059447

Tinnitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tinnitus Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACT + sound therapy group

The combined treatment group will receive Internet-delivered guided self-help tinnitus treatment based on ACT combined with customized sound therapy.

The online ACT program includes 8 modules of structured self-help material over 8 weeks. Each module includes information, exercises, and homework. The self-help material covers the six core processes of ACT: acceptance, cognitive defusion, being present, self-as-context, values, and committed action, emphasizing psychological flexibility.

Customized sound therapy will be provided by the Fudan Tinnitus Relieving System (FTRS) app. Participants will listen to tailor-made music through the app for more than two hours per day.

Group Type EXPERIMENTAL

ACT for tinnitus

Intervention Type BEHAVIORAL

The intervention will be based on the ACT model and adjusted for tinnitus.

Customized sound therapy

Intervention Type OTHER

The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.

sound therapy group

The single treatment group will receive customized sound therapy provided by the FTRS app for more than two hours per day.

Group Type ACTIVE_COMPARATOR

Customized sound therapy

Intervention Type OTHER

The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACT for tinnitus

The intervention will be based on the ACT model and adjusted for tinnitus.

Intervention Type BEHAVIORAL

Customized sound therapy

The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 15 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No