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NCT Number: NCT05963542

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

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.

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Key information

Conditions

Tinnitus Dyssomnias Ear Diseases Hearing Disorders Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged between 18 and 80 years old.
  • Experiencing subjective tinnitus for at least 3 months.
  • A score of 38 or more on THI.
  • A score of 8 or more on ISI.
  • 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
  • Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material.

Exclusion criteria

  • Pulsatile tinnitus and objective tinnitus.
  • Organic sleep disorders.
  • Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss).
  • Severe mental illness.
  • Undergoing other research that may affect tinnitus and sleep.

Treatment and study plan

ACT for tinnitus

Behavioral

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

Customized sound therapy

Other

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

Primary outcomes

  1. Tinnitus Handicap Inventory (THI)

    Time frame: 2 months from baseline

    The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

  2. Tinnitus Handicap Inventory (THI)

    Time frame: 3 months from baseline

    The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

  3. Tinnitus Handicap Inventory (THI)

    Time frame: 5 months from baseline

    The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 2 months from baseline

    ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28).

  2. Insomnia Severity Index (ISI)

    Time frame: 3 months from baseline

    ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28).

  3. Insomnia Severity Index (ISI)

    Time frame: 5 months from baseline

    ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28).

  4. Visual Analogue Scale (VAS)

    Time frame: 2 months from baseline

    Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).

  5. Visual Analogue Scale (VAS)

    Time frame: 3 months from baseline

    Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).

  6. Visual Analogue Scale (VAS)

    Time frame: 5 months from baseline

    Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).

  7. Hospital Anxiety and Distress Scale (HADS)

    Time frame: 2 months from baseline

    HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression.

  8. Hospital Anxiety and Distress Scale (HADS)

    Time frame: 3 months from baseline

    HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression.

  9. Hospital Anxiety and Distress Scale (HADS)

    Time frame: 5 months from baseline

    HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression.

  10. Tinnitus Acceptance Questionnaire (TAQ)

    Time frame: 2 months from baseline

    TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance.

  11. Tinnitus Acceptance Questionnaire (TAQ)

    Time frame: 3 months from baseline

    TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance.

  12. Tinnitus Acceptance Questionnaire (TAQ)

    Time frame: 5 months from baseline

    TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance.

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

SoundMind Trial: a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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