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Efficacy of Amplification With Hearing Aids for Tinnitus Relief

Primary Purpose

Tinnitus, Subjective, Hearing Impairment

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Amplification with hearing aid
Customized music
Sponsored by
Education University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective focused on measuring Tinnitus, Hearing Loss, Amplification, Sound Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years old or above
  • can provide written informed consent
  • have a diagnosis of subjective tinnitus, i.e., the tinnitus can only be heard by the patient and there is no acoustic source
  • a tinnitus duration of more than one year
  • have pure-tone average between 20 and 40 dB HL
  • have bilateral symmetrical hearing loss (i.e. difference less than 15 dB)
  • have at least a medium level of distress caused by tinnitus as indicated with total scores above 30 on the TQ-CH
  • are committed to complete the 12-month follow-up

Exclusion Criteria:

  • objective tinnitus, i.e. tinnitus produced by an internal acoustic source activating the cochlea and can be heard by another person
  • received other forms of tinnitus treatments within three months before the baseline assessment session
  • any history suggestive of psychiatric illness
  • psychological distress or depression as indicated with total scores at or above 15 on the Cantonese HADS
  • current hearing aid users
  • inability to complete the study as revealed by the medical reports

Sites / Locations

  • The Education University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Waiting list control group

Hearing aid group

Customized music group

Arm Description

There will be no treatment for 12 months.

Participants will receive amplification with hearing aids. Bilateral open-fit hearing aids will be fitted. Participants will be required to use the hearing aids for at least 2 hours daily for 12 months.

Customized music according to participants hearing level will be made available in an iPod. The iPod will deliver ear-specific therapeutic sound for asymmetrical hearing profile. Participants will have to listen to the therapeutic sound at a comfortable volume for two hours daily for 12 months.

Outcomes

Primary Outcome Measures

The Tinnitus Functional Index (Chinese version) (TFI-CH)
TFI-CH is a 25-item self-administered questionnaire which assesses eight domains of tinnitus impact: intrusiveness; sense of control; cognitive; sleep; auditory; relaxation; quality of life (QoL); emotion. The total TFI score ranges 0 - 100, the higher score is indicative of greater problem with tinnitus.

Secondary Outcome Measures

The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores
The TQ-CH is a 52-item questionnaire which assesses five dimensions of tinnitus complaint: emotional distress; auditory perceptual difficulties; intrusiveness; sleep disturbance; and somatic complaints. The total TQ score ranges 0 - 104, the higher score is indicative of greater problem with tinnitus.
The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores
The THI-CH is a reliable 25-item self-administered Chinese QoL tool that quantifies the impact of tinnitus on daily living. The total THI score ranges 0 - 100, the higher score is indicative of greater tinnitus handicap.
Self-rated Visual Analogue Scale (VAS) on tinnitus loudness
The subjects will be asked to rate the perceived loudness of their tinnitus on VAS, with "inaudible" (scale rating value = 0) and "very loud" (scale rating value = 100) as reference points for the ends of the scale. The higher rating is indicative of louder tinnitus.
Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz
Tinnitus loudness matches will be done according to Vernon and Meikle's procedure
The Chinese Hospital Anxiety and Depression Scale (HADS)
The Chinese HADS is a 14-item questionnaire that consists of two subscales that measure anxiety and depression. It serves as an outcome measure targeting psychological and mental health effects.

Full Information

First Posted
October 17, 2018
Last Updated
September 5, 2023
Sponsor
Education University of Hong Kong
Collaborators
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03716544
Brief Title
Efficacy of Amplification With Hearing Aids for Tinnitus Relief
Official Title
Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Education University of Hong Kong
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control).
Detailed Description
Acoustic stimulation could induce plastic changes in the auditory cortex, and tinnitus mechanisms have been viewed as a negative consequence of neural plasticity in the central nervous system after peripheral aggression. Cortical changes (neural activity in the deafferented cortical area was reduced but the adjacent frequencies of the hearing loss region activated more extensive cortical areas) occur after sensorineural hearing loss, while exposure to an acoustically enriched environment or using hearing aids may minimize or reverse the plastic tonotopic map changes in the auditory cortex. The use of hearing aids in tinnitus management for people with significant hearing loss will always be associated with an improvement in hearing handicap and quality of life, and that complicates the interpretation of how much hearing aids specifically affect tinnitus. Thus studies on tinnitus patients with mild hearing loss could be illuminating, and this population will be targeted in the present study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective, Hearing Impairment
Keywords
Tinnitus, Hearing Loss, Amplification, Sound Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
There will be no treatment for 12 months.
Arm Title
Hearing aid group
Arm Type
Experimental
Arm Description
Participants will receive amplification with hearing aids. Bilateral open-fit hearing aids will be fitted. Participants will be required to use the hearing aids for at least 2 hours daily for 12 months.
Arm Title
Customized music group
Arm Type
Active Comparator
Arm Description
Customized music according to participants hearing level will be made available in an iPod. The iPod will deliver ear-specific therapeutic sound for asymmetrical hearing profile. Participants will have to listen to the therapeutic sound at a comfortable volume for two hours daily for 12 months.
Intervention Type
Device
Intervention Name(s)
Amplification with hearing aid
Other Intervention Name(s)
Hearing aid group
Intervention Description
Use of hearing aids
Intervention Type
Device
Intervention Name(s)
Customized music
Intervention Description
Customized music delivered via an iPod
Primary Outcome Measure Information:
Title
The Tinnitus Functional Index (Chinese version) (TFI-CH)
Description
TFI-CH is a 25-item self-administered questionnaire which assesses eight domains of tinnitus impact: intrusiveness; sense of control; cognitive; sleep; auditory; relaxation; quality of life (QoL); emotion. The total TFI score ranges 0 - 100, the higher score is indicative of greater problem with tinnitus.
Time Frame
Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary Outcome Measure Information:
Title
The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores
Description
The TQ-CH is a 52-item questionnaire which assesses five dimensions of tinnitus complaint: emotional distress; auditory perceptual difficulties; intrusiveness; sleep disturbance; and somatic complaints. The total TQ score ranges 0 - 104, the higher score is indicative of greater problem with tinnitus.
Time Frame
Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Title
The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores
Description
The THI-CH is a reliable 25-item self-administered Chinese QoL tool that quantifies the impact of tinnitus on daily living. The total THI score ranges 0 - 100, the higher score is indicative of greater tinnitus handicap.
Time Frame
Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Title
Self-rated Visual Analogue Scale (VAS) on tinnitus loudness
Description
The subjects will be asked to rate the perceived loudness of their tinnitus on VAS, with "inaudible" (scale rating value = 0) and "very loud" (scale rating value = 100) as reference points for the ends of the scale. The higher rating is indicative of louder tinnitus.
Time Frame
Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Title
Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz
Description
Tinnitus loudness matches will be done according to Vernon and Meikle's procedure
Time Frame
Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Title
The Chinese Hospital Anxiety and Depression Scale (HADS)
Description
The Chinese HADS is a 14-item questionnaire that consists of two subscales that measure anxiety and depression. It serves as an outcome measure targeting psychological and mental health effects.
Time Frame
Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years old or above can provide written informed consent have a diagnosis of subjective tinnitus, i.e., the tinnitus can only be heard by the patient and there is no acoustic source a tinnitus duration of more than one year have pure-tone average between 20 and 40 dB HL have bilateral symmetrical hearing loss (i.e. difference less than 15 dB) have at least a medium level of distress caused by tinnitus as indicated with total scores above 30 on the TQ-CH are committed to complete the 12-month follow-up Exclusion Criteria: objective tinnitus, i.e. tinnitus produced by an internal acoustic source activating the cochlea and can be heard by another person received other forms of tinnitus treatments within three months before the baseline assessment session any history suggestive of psychiatric illness psychological distress or depression as indicated with total scores at or above 15 on the Cantonese HADS current hearing aid users inability to complete the study as revealed by the medical reports
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna CS KAM, AuD
Organizational Affiliation
The Education University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Education University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Amplification With Hearing Aids for Tinnitus Relief

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