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Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention (EEG-RCT)

Primary Purpose

Tinnitus, Subjective

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
music therapy
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 - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-30 years old, male or female;
  2. PTA (0.5,1,2kHz) ≤25dB HL;
  3. Tinnitus is a major problem faced by patients (except healthy volunteers);
  4. tinnitus course > for 3 months;
  5. Healthy, no history of other ear diseases, no history of hearing impairment;
  6. There are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment;
  7. Voluntary tinnitus treatment, and have enough time to cooperate with treatment.

Exclusion Criteria:

  1. Pulsatile tinnitus;
  2. Acute tinnitus;
  3. Tinnitus is associated with severe hearing loss;
  4. Tinnitus accompanied by vertigo;
  5. Tinnitus accompanied by headache;
  6. Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder;
  7. Post-traumatic tinnitus;
  8. Tinnitus is associated with serious psychiatric complications;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Placebo Comparator

    Experimental

    Arm Label

    volunteer

    patients with unmodified music group

    patients with modified tinnitus relieving music

    Arm Description

    40 volunteer will not accept any treatment

    40 participants in this group will listen to music without any modification

    40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch

    Outcomes

    Primary Outcome Measures

    electroencephalogram evaluation
    latency
    electroencephalogram evaluation
    peak
    electroencephalogram evaluation
    amplitude
    the loudness of tinnitus
    estimated by auditory facility, recorded by unit of dB
    the frequency of tinnitus
    estimated by auditory facility, recorded by unit of Hz
    minimum masking level
    the minimum volume to masking tinnitus, recorded by unit of dB
    Tinnitus Handicapped Inventory
    Tinnitus disability is divided into four levels, the first level: 0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.
    Hospital Anxiety and Distress Scale
    0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 16, 2020
    Last Updated
    July 2, 2020
    Sponsor
    Eye & ENT Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04449237
    Brief Title
    Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
    Acronym
    EEG-RCT
    Official Title
    The Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.
    Detailed Description
    Tinnitus is one of the most common auditory disturbances in human. The treatment of tinnitus is always not effective, and the standardized treatment of tinnitus has been lacking. With the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the central mechanism of tinnitus has been gradually revealed. The possible mechanisms of tinnitus are the increase of spontaneous discharge rate and synchronization of auditory central neurons caused by hearing deprivation, the change of brain topological structure, the reorganization of auditory cortex, and the disorder of limbic system and auditory central regulation of tinnitus patients. EEG, as an important means to study the cerebral cortex, has become an important technical support for the research on the central mechanism of tinnitus. Changes in activity in auditory brain areas associated with tinnitus have been observed using EEG/ERPs, and non-auditory brain areas such as the limbic system and frontal cortices have also been associated with tinnitus mechanisms. This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus, Subjective

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    volunteer
    Arm Type
    Other
    Arm Description
    40 volunteer will not accept any treatment
    Arm Title
    patients with unmodified music group
    Arm Type
    Placebo Comparator
    Arm Description
    40 participants in this group will listen to music without any modification
    Arm Title
    patients with modified tinnitus relieving music
    Arm Type
    Experimental
    Arm Description
    40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch
    Intervention Type
    Other
    Intervention Name(s)
    music therapy
    Intervention Description
    music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.
    Primary Outcome Measure Information:
    Title
    electroencephalogram evaluation
    Description
    latency
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month
    Title
    electroencephalogram evaluation
    Description
    peak
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month
    Title
    electroencephalogram evaluation
    Description
    amplitude
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month
    Title
    the loudness of tinnitus
    Description
    estimated by auditory facility, recorded by unit of dB
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month
    Title
    the frequency of tinnitus
    Description
    estimated by auditory facility, recorded by unit of Hz
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month
    Title
    minimum masking level
    Description
    the minimum volume to masking tinnitus, recorded by unit of dB
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month
    Title
    Tinnitus Handicapped Inventory
    Description
    Tinnitus disability is divided into four levels, the first level: 0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month
    Title
    Hospital Anxiety and Distress Scale
    Description
    0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.
    Time Frame
    From date of randomization, assessed every 3 month, up to 24 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-30 years old, male or female; PTA (0.5,1,2kHz) ≤25dB HL; Tinnitus is a major problem faced by patients (except healthy volunteers); tinnitus course > for 3 months; Healthy, no history of other ear diseases, no history of hearing impairment; There are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment; Voluntary tinnitus treatment, and have enough time to cooperate with treatment. Exclusion Criteria: Pulsatile tinnitus; Acute tinnitus; Tinnitus is associated with severe hearing loss; Tinnitus accompanied by vertigo; Tinnitus accompanied by headache; Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder; Post-traumatic tinnitus; Tinnitus is associated with serious psychiatric complications;

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

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