Tinnitus, Subjective Clinical Trial
Official title:
Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial
Verified date | March 2024 |
Source | Education University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Education University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Education University of Hong Kong | Chinese University of Hong Kong |
Hong Kong,
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. |
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