Efficacy of Amplification With Hearing Aids for Tinnitus Relief

Tinnitus, Subjective Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716544
• Other study ID #: RGC18100117
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Education University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss
• Tinnitus
• Tinnitus, Subjective

Intervention

Device:
• Amplification with hearing aid
Use of hearing aids
• Customized music
Customized music delivered via an iPod

Locations

Country	Name	City	State
Hong Kong	The Education University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Education University of Hong Kong	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary	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.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary	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.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary	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.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary	Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz	Tinnitus loudness matches will be done according to Vernon and Meikle's procedure	Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary	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.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.