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Completed

NCT Number: NCT03716544

Efficacy of Amplification With Hearing Aids for Tinnitus Relief

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).

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Key information

Conditions

Tinnitus, Subjective Ear Diseases Hearing Disorders Hearing Impairment Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Education University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amplification with hearing aid

Device

Use of hearing aids

Other names: Hearing aid group

Customized music

Device

Customized music delivered via an iPod

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Official study title

Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2018
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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