None listed
Conditions
Interventions
Behavioral : The intervention in this study is an auditory-attention neurofeedback activity. The intervention will be conducted over four sessions from the second to the fifth visit, and each session
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 19 years or older Participants with bilateral sensorineural hearing loss Participants who can understand Korean sentences For hearing aid users, participants whose hearing levels are similar between both ears after hearing aid fitting For hearing aid users, participants who have used hearing aids for at least 3 months and use them for an average of at least 4 hours per day For hearing aid users, participants with mild, moderate, or moderately severe hearing loss according to the WHO 2021 grading system ? Defined as a four-frequency pure-tone average at 500, 1000, 2000, and 4000 Hz in the better-hearing ear of 20 dB to <65 dB HL For non-hearing aid users, participants with mild or moderate hearing loss according to the WHO 2021 grading system ? Defined as a four-frequency pure-tone average at 500, 1000, 2000, and 4000 Hz in the better-hearing ear of 20 dB to <50 dB HL
Exclusion criteria
Exclusion criteria: - For hearing aid users, participants who have used hearing aids for 3 months or less - For hearing aid users, participants whose hearing levels are asymmetric between both ears after hearing aid fitting. Asymmetry is defined as a difference of 20 dB HL or more at two or more consecutive frequencies - Participants with moderate or greater cognitive or psychiatric impairment, including those with a K-MMSE score below 24 or an PHQ-9 score of 20 or higher - Participants who have difficulty cooperating with the tests due to communication problems - Participants who have secondary gain related to participation in the clinical trial - Participants judged by the principal investigator to be inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in speech-in-noise perception threshold. The change in SRT50 threshold derived from the sentence-based speech-in-noise assessment before and after the neurofeedback activity will be evaluated, and the difference between the experimental and control groups will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in EEG measures during the speech-in-noise assessment. Changes in EEG signals measured during the speech-in-noise assessment before and after the neurofeedback activity will be evaluated, and the difference between the experimental and control groups will be compared.;Change in EEG measures across neurofeedback sessions. Session-by-session changes in EEG signals measured during the neurofeedback activity from the second to the fifth visit will be evaluated, and the difference between the experimental and control groups will be compared.;Correlation between EEG changes across neurofeedback sessions and speech-in-noise assessment results. The association between EEG changes measured during the neurofeedback activity and speech-in-noise assessment results will be evaluated.;Change in cognitive function test results. Changes in cognitive function test results before and after the neurofeedback activity will be evaluated, and the difference between the experimental and control groups will be compared. | — |
Countries
Korea, Republic of
Contacts
Public ContactHee Jung Yun
Samsung Medical Center
Outcome results
None listed