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Efficacy of Amplification With Hearing Aids for Tinnitus Relief

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ClinicalTrials.gov Identifier: NCT03716544
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
KAM Chi Shan Anna, Education University of Hong Kong

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).

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Hearing Impairment Device: Amplification with hearing aid Device: Customized music Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Waiting list control group
There will be no treatment for 12 months.
Experimental: Hearing aid group
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.
Device: Amplification with hearing aid
Use of hearing aids
Other Name: Hearing aid group

Active Comparator: Customized music group
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.
Device: Customized music
Customized music delivered via an iPod




Primary Outcome Measures :
  1. The Tinnitus Functional Index (Chinese version) (TFI-CH) [ Time Frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured. ]
    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 :
  1. The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores [ Time Frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured. ]
    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.

  2. The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores [ Time Frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured. ]
    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.

  3. Self-rated Visual Analogue Scale (VAS) on tinnitus loudness [ Time Frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured. ]
    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.

  4. Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz [ Time Frame: Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured. ]
    Tinnitus loudness matches will be done according to Vernon and Meikle's procedure

  5. The Chinese Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716544


Contacts
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Contact: Anna CS KAM, AuD 85229488194 annakam@eduhk.hk

Locations
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Hong Kong
The Education University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Anna CS Kam, AuD    29488194    annakam@eduhk.hk   
Sponsors and Collaborators
Education University of Hong Kong
Chinese University of Hong Kong
Investigators
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Principal Investigator: Anna CS KAM, AuD The Education University of Hong Kong

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Responsible Party: KAM Chi Shan Anna, Assistant Professor, Education University of Hong Kong
ClinicalTrials.gov Identifier: NCT03716544    
Other Study ID Numbers: RGC18100117
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by KAM Chi Shan Anna, Education University of Hong Kong:
Tinnitus
Hearing Loss
Amplification
Sound Therapy
Additional relevant MeSH terms:
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Tinnitus
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms