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Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss

Primary Purpose

Tinnitus, Subjective, Hearing Loss, High-Frequency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aids
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults aged older than 18 years old and less than 70 years;
  2. Chronic (>6 months) subjective tinnitus, unilateral or bilateral;
  3. Diagnosed with a high-frequency SNHL;
  4. Be available for six months after starting the study to complete the follow-up questionnaires;
  5. Readiness to participate in the study and sign the informed consent.
  6. Be covered by public health insurance and eligible for reimbursement.

Exclusion Criteria:

  1. Objective tinnitus;
  2. Conductive HL;
  3. Unstable medical history that limits participation;
  4. Undergoing any other concurrent treatments on tinnitus or HL;
  5. Having used HAs in the past 1 year;
  6. Unwilling or unable to use HAs daily;
  7. Alcohol or drug abuse;
  8. Unable to read or write.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    HA treatment group

    non-HA treatment group

    Arm Description

    Participants in the treatment group are required to wear the HAs for at least 3 hours per day, with 24 days per month. Additionally, they will receive regular counseling and lifestyle education from their physicians.

    Non-HA treatment group is a waiting list control group (WLC) in which participants will receive the intervention after the waiting period has passed. They will only receive regular counseling and lifestyle education from their physicians in this waiting period.

    Outcomes

    Primary Outcome Measures

    tinnitus handicap inventory (THI)
    The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.
    tinnitus handicap inventory (THI)
    The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.

    Secondary Outcome Measures

    speech recognition score (SRS) test
    The list consists of 25 monosyllabic words, and each word is rated on a 4-point scale with a total score of 100. A higher score indicates a better level of auditory comprehension and speech recognition.
    speech recognition score (SRS) test
    The list consists of 25 monosyllabic words, and each word is rated on a 4-point scale with a total score of 100. A higher score indicates a better level of auditory comprehension and speech recognition.
    pure tone audiometry (PTA)
    PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
    pure tone audiometry (PTA)
    PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
    otoacoustic emission (OAE)
    OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
    otoacoustic emission (OAE)
    OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
    the Hospital Anxiety and Depression Scale (HADs)
    The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21).
    the Hospital Anxiety and Depression Scale (HADs)
    The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21).
    the Athens Insomnia Scale-8 (AIS-8)
    The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
    the Athens Insomnia Scale-8 (AIS-8)
    The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).

    Full Information

    First Posted
    April 18, 2022
    Last Updated
    April 21, 2022
    Sponsor
    Eye & ENT Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05343026
    Brief Title
    Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss
    Official Title
    Efficacy of Hearing-aid Treatment on Sound Perception and Residual Hearing Preservation for Patients With Tinnitus and Co-existing Hearing Loss: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eye & ENT Hospital of Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Considering the extent to which HAs play a role in sound perception and residual hearing preservation among patients with tinnitus and co-existing HL remains a lack of compelling extensive evidence, investigators designed this single-blind, 6-months randomized, controlled trial with two parallel groups. One is the HA treatment group, and the other is the waiting list control (WLC) group which receives no interventions during this period.
    Detailed Description
    In clinical practice, chronic subject tinnitus poses an important challenge. This condition can negatively affect an individual's emotional and functional well-being. In most cases, tinnitus is highly associated with hearing impairment, particularly in cases of high-frequency sensorineural hearing loss (SNHL). The occurrence of tinnitus in patients with HL is one of the most prevalent sensory disabilities, causing a deleterious effect on patients' lives. Nowadays, the mild to moderate SNHL can be effectively managed with a fitting hearing aid (HA) by providing sound amplification, and several findings suggest that the HA may also be helpful for people with tinnitus. Nevertheless, in terms of the effects of HA use for residual hearing protection for patients with tinnitus and co-existing hearing loss, inadequate attention is still paid by medical personnel, and relevant evidence remains preliminary at this point in time. To assess the full extent of tinnitus patients, investigators need to carry out a series of tests, including hearing assessment and psychometric tests. Pure tone audiometry (PTA) and otoacoustic emission (OAE) tests are used to calculate the average hearing thresholds and the outer hair cell function, while the Tinnitus hazard Index (THI), the Visual Analogue Scale (VAS), the Hospital Anxiety and the Depression Scale (HADs) and the Athens Insomnia Scale-8 (AIS-8) questionnaires were for patients' psychology status. Investigators hypothesize that in patients with tinnitus and hearing loss, HA intervention results in better conditions of tinnitus and lower hearing threshold reduction. Here investigators planned to enroll patients into two groups, the HA and non-HA (served as the control) intervention patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus, Subjective, Hearing Loss, High-Frequency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HA treatment group
    Arm Type
    Experimental
    Arm Description
    Participants in the treatment group are required to wear the HAs for at least 3 hours per day, with 24 days per month. Additionally, they will receive regular counseling and lifestyle education from their physicians.
    Arm Title
    non-HA treatment group
    Arm Type
    No Intervention
    Arm Description
    Non-HA treatment group is a waiting list control group (WLC) in which participants will receive the intervention after the waiting period has passed. They will only receive regular counseling and lifestyle education from their physicians in this waiting period.
    Intervention Type
    Device
    Intervention Name(s)
    Hearing aids
    Intervention Description
    As for screening the hearing and tinnitus testing, the measure typically comprises PTA, SRS, DPOAE, and several widely accepted standardized tinnitus questionnaires, including the THI for tinnitus severity and VAS for tinnitus loudness.
    Primary Outcome Measure Information:
    Title
    tinnitus handicap inventory (THI)
    Description
    The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.
    Time Frame
    3 months from baseline
    Title
    tinnitus handicap inventory (THI)
    Description
    The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.
    Time Frame
    6 months from baseline
    Secondary Outcome Measure Information:
    Title
    speech recognition score (SRS) test
    Description
    The list consists of 25 monosyllabic words, and each word is rated on a 4-point scale with a total score of 100. A higher score indicates a better level of auditory comprehension and speech recognition.
    Time Frame
    3 months from baseline
    Title
    speech recognition score (SRS) test
    Description
    The list consists of 25 monosyllabic words, and each word is rated on a 4-point scale with a total score of 100. A higher score indicates a better level of auditory comprehension and speech recognition.
    Time Frame
    6 months from baseline
    Title
    pure tone audiometry (PTA)
    Description
    PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
    Time Frame
    3 months from baseline
    Title
    pure tone audiometry (PTA)
    Description
    PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
    Time Frame
    6 months from baseline
    Title
    otoacoustic emission (OAE)
    Description
    OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
    Time Frame
    3 months from baseline
    Title
    otoacoustic emission (OAE)
    Description
    OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
    Time Frame
    6 months from baseline
    Title
    the Hospital Anxiety and Depression Scale (HADs)
    Description
    The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21).
    Time Frame
    3 months from baseline
    Title
    the Hospital Anxiety and Depression Scale (HADs)
    Description
    The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21).
    Time Frame
    6 months from baseline
    Title
    the Athens Insomnia Scale-8 (AIS-8)
    Description
    The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
    Time Frame
    3 months from baseline
    Title
    the Athens Insomnia Scale-8 (AIS-8)
    Description
    The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
    Time Frame
    6 months from baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults aged older than 18 years old and less than 70 years; Chronic (>6 months) subjective tinnitus, unilateral or bilateral; Diagnosed with a high-frequency SNHL; Be available for six months after starting the study to complete the follow-up questionnaires; Readiness to participate in the study and sign the informed consent. Be covered by public health insurance and eligible for reimbursement. Exclusion Criteria: Objective tinnitus; Conductive HL; Unstable medical history that limits participation; Undergoing any other concurrent treatments on tinnitus or HL; Having used HAs in the past 1 year; Unwilling or unable to use HAs daily; Alcohol or drug abuse; Unable to read or write.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sun
    Phone
    +86-18917786102
    Email
    sunshine7896@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peifan Li
    Phone
    +86-18373151369
    Email
    20211260020@fudan.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shan Sun
    Organizational Affiliation
    Eye and ENT Hospital of Fudan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss

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