xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05963542</url>
    </required_header>
    <id_info>
      <org_study_id>2023066-1</org_study_id>
      <nct_id>NCT05963542</nct_id>
    </id_info>
    <brief_title>Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia</brief_title>
    <official_title>SoundMind Trial: a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eye &amp; ENT Hospital of Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eye &amp; ENT Hospital of Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Considering the lack of evidence on the effects of combining acceptance and commitment&#xD;
        therapy (ACT) with customized sound therapy for tinnitus-related insomnia patients,&#xD;
        investigators designed this single-blind, 6-months randomized, controlled trial with two&#xD;
        parallel groups. One is the ACT + sound therapy group, and the other is the sound therapy&#xD;
        group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Insomnia is one of the most frequent and severe comorbidities in patients with tinnitus and&#xD;
        is highly relevant for the perceived tinnitus severity. Both tinnitus and insomnia&#xD;
        significantly affect the quality of life of patients and represent a huge burden to society.&#xD;
        While interventions exist to alleviate tinnitus distress, they often do not address sleep&#xD;
        disturbances in tinnitus patients. Patients affected by tinnitus and insomnia suffer from&#xD;
        long-term functional and psychological problems. Sound therapy is widely used to treat&#xD;
        tinnitus, often combined with education and counseling, and can effectively improve the&#xD;
        quality of life. In addition, acceptance and commitment therapy (ACT) for tinnitus improves&#xD;
        both tinnitus and sleep. However, there is a lack of evidence on the effects of combining ACT&#xD;
        with sound therapy for tinnitus-related insomnia patients.&#xD;
  &#xD;
        To fully characterize tinnitus patients, standardized measures of tinnitus and insomnia are&#xD;
        essential. These measures include pure tone audiometry (PTA), acoustic immittance (AI),&#xD;
        tinnitus pitch matching (PM) and loudness matching (LM), minimum masking level (MML),&#xD;
        tinnitus handicap inventory (THI), insomnia severity index (ISI), and hospital anxiety and&#xD;
        depression scale (HADS).&#xD;
  &#xD;
        Investigators hypothesize that the combination of ACT and sound therapy will be&#xD;
        non-inferiority to sound therapy alone in reducing tinnitus distress.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tinnitus Handicap Inventory (THI)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a &quot;yes&quot; (4 points), &quot;sometimes&quot; (2 points), and &quot;no&quot; (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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tinnitus Handicap Inventory (THI)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a &quot;yes&quot; (4 points), &quot;sometimes&quot; (2 points), and &quot;no&quot; (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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tinnitus Handicap Inventory (THI)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a &quot;yes&quot; (4 points), &quot;sometimes&quot; (2 points), and &quot;no&quot; (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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Onset Latency (SOL)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Onset Latency (SOL)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Onset Latency (SOL)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wake After Sleep Onset (WASO)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wake After Sleep Onset (WASO)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wake After Sleep Onset (WASO)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Efficiency (SE)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Efficiency (SE)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Efficiency (SE)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Distress Scale (HADS)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Distress Scale (HADS)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Distress Scale (HADS)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tinnitus Acceptance Questionnaire (TAQ)</measure>
      <time_frame>2 months from baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tinnitus Acceptance Questionnaire (TAQ)</measure>
      <time_frame>3 months from baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tinnitus Acceptance Questionnaire (TAQ)</measure>
      <time_frame>6 months from baseline</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">118</enrollment>
    <condition>Tinnitus</condition>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>ACT + sound therapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The combined treatment group will receive Internet-delivered guided self-help tinnitus treatment based on ACT combined with customized sound therapy.&#xD;
  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.&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sound therapy group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The single treatment group will receive customized sound therapy provided by the FTRS app for more than two hours per day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>ACT for tinnitus</intervention_name>
      <description>The intervention will be based on the ACT model and adjusted for tinnitus.</description>
      <arm_group_label>ACT + sound therapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Customized sound therapy</intervention_name>
      <description>The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.</description>
      <arm_group_label>ACT + sound therapy group</arm_group_label>
      <arm_group_label>sound therapy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults aged between 18 and 80 years old.&#xD;
  &#xD;
            2. Experiencing subjective tinnitus for at least 3 months.&#xD;
  &#xD;
            3. A score of 38 or more on THI.&#xD;
  &#xD;
            4. A score of 15 or more on ISI.&#xD;
  &#xD;
            5. 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.&#xD;
  &#xD;
            6. Ability to read and write in Chinese and use a smartphone with an internet connection&#xD;
               to work with text material.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pulsatile tinnitus and objective tinnitus.&#xD;
  &#xD;
            2. Organic sleep disorders.&#xD;
  &#xD;
            3. Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis,&#xD;
               Meniere's disease, the acute stage of sudden sensorineural hearing loss).&#xD;
  &#xD;
            4. Severe mental illness.&#xD;
  &#xD;
            5. Undergoing other research that may affect tinnitus and sleep.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Huawei Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Eye and ENT Hospital of Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shan Sun</last_name>
      <phone>+86-021-64377134-2033</phone>
      <email>sunshine7896@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dongmei Tang</last_name>
      <phone>+86-13023299189</phone>
      <email>tang.dongm@163.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tinnitus</mesh_term>
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05963542
  org study id: 2023066-1
  nct id: NCT05963542
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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
        non-inferiority to sound therapy alone in reducing tinnitus distress.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Tinnitus Handicap Inventory (THI)
  time frame: 2 months from baseline
  description: 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).
  measure: Tinnitus Handicap Inventory (THI)
  time frame: 3 months from baseline
  description: 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).
  measure: Tinnitus Handicap Inventory (THI)
  time frame: 6 months from baseline
  description: 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).
  measure: Insomnia Severity Index (ISI)
  time frame: 2 months from baseline
  description: 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).
  measure: Insomnia Severity Index (ISI)
  time frame: 3 months from baseline
  description: 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).
  measure: Insomnia Severity Index (ISI)
  time frame: 6 months from baseline
  description: 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).
  measure: Sleep Onset Latency (SOL)
  time frame: 2 months from baseline
  description: SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.
  measure: Sleep Onset Latency (SOL)
  time frame: 3 months from baseline
  description: SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.
  measure: Sleep Onset Latency (SOL)
  time frame: 6 months from baseline
  description: SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.
  measure: Wake After Sleep Onset (WASO)
  time frame: 2 months from baseline
  description: WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.
  measure: Wake After Sleep Onset (WASO)
  time frame: 3 months from baseline
  description: WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.
  measure: Wake After Sleep Onset (WASO)
  time frame: 6 months from baseline
  description: WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep.
  measure: Sleep Efficiency (SE)
  time frame: 2 months from baseline
  description: SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep.
  measure: Sleep Efficiency (SE)
  time frame: 3 months from baseline
  description: SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep.
  measure: Sleep Efficiency (SE)
  time frame: 6 months from baseline
  description: SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep.
  measure: Visual Analogue Scale (VAS)
  time frame: 2 months from baseline
  description: 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).
  measure: Visual Analogue Scale (VAS)
  time frame: 3 months from baseline
  description: 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).
  measure: Visual Analogue Scale (VAS)
  time frame: 6 months from baseline
  description: 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).
  measure: Hospital Anxiety and Distress Scale (HADS)
  time frame: 2 months from baseline
  description: 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.
  measure: Hospital Anxiety and Distress Scale (HADS)
  time frame: 3 months from baseline
  description: 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.
  measure: Hospital Anxiety and Distress Scale (HADS)
  time frame: 6 months from baseline
  description: 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.
  measure: Tinnitus Acceptance Questionnaire (TAQ)
  time frame: 2 months from baseline
  description: 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.
  measure: Tinnitus Acceptance Questionnaire (TAQ)
  time frame: 3 months from baseline
  description: 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.
  measure: Tinnitus Acceptance Questionnaire (TAQ)
  time frame: 6 months from baseline
  description: 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.
  arm group label: ACT + sound therapy group
  arm group type: Experimental
  description: 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.
  arm group label: sound therapy group
  arm group type: Active Comparator
  description: The single treatment group will receive customized sound therapy provided by the FTRS app for more than two hours per day.
  intervention type: Behavioral
  intervention name: ACT for tinnitus
  description: The intervention will be based on the ACT model and adjusted for tinnitus.
  arm group label: ACT + sound therapy group
  intervention type: Other
  intervention name: Customized sound therapy
  description: The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.
  arm group label: ACT + sound therapy group
  arm group label: sound therapy group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Huawei Li
  role: Principal Investigator
  affiliation: Eye and ENT Hospital of Fudan University
  last name: Shan Sun
  phone: +86-021-64377134-2033
  email: sunshine7896@126.com
  last name: Dongmei Tang
  phone: +86-13023299189
  email: tang.dongm@163.com
  responsible party type: Sponsor
  mesh term: Tinnitus
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No