Clinical trial NCT03716544: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Hearing Impairment
Keywords: Tinnitus
Hearing Loss
Amplification
Sound Therapy
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2018-10-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Tinnitus Functional Index (Chinese version) (TFI-CH)
timeFrame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary outcomes:
measure: The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores
timeFrame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
measure: The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores
timeFrame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
measure: Self-rated Visual Analogue Scale (VAS) on tinnitus loudness
timeFrame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
measure: Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz
timeFrame: Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured.
measure: The Chinese Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Education University of Hong Kong
Study officials:
affiliation: The Education University of Hong Kong
name: Anna CS KAM, AuD
role: PRINCIPAL_INVESTIGATOR
References: