Clinical trial NCT06893432: Cognitive Function and EEG Brain Network Remodeling Among Users of Hearing Aids With ARHL
Official title: Cognitive Function and Electroencephalogram Brain Network Remodeling Among Users of Hearing Aids With Age-Related Hearing Loss
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Age-related Hearing Loss
Age-related Cognitive Decline
Depression
Sleep Disturbance
Keywords: age-related hearing loss
cognition
electroencephalogram
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study, we retrospectively collect clinical data of patients with ARHL who have attended the Otolaryngology Department of Sun Yat-sen Memorial Hospital from January 2020 to June 2024. All participants are native speakers of Mandarin Chinese or Cantonese (Guangdong, China). Candidates will be excluded for outer/middle ear abnormalities or any other central nervous system disorders. Thereafter, all participants were grouped depending on whether they have regularly used hearing aid(s) to improve hearing during the past six-month period.

Brief summary: This study intends to retrospectively collect and analyze the case data of patients with age-related hearing loss who were admitted to the Otolaryngology Department of Sun Yat-sen Memorial Hospital from January 2020 to June 2024. Participants were divided into an Aided Group and a Control Group based on whether they had regularly used hearing aids in the past six months.

Audiological, cognitive, emotional, and sleep assessments, as well as resting state electroencephalogram (EEG) features, are supposed to be compared between the two groups.

Detailed description: This study intends to retrospectively collect and analyze the case data of patients with age-related hearing loss who were admitted to the Otolaryngology Department of Sun Yat-sen Memorial Hospital from January 2020 to June 2024. Participants were divided into an Aided Group and a Control Group based on whether they had regularly used hearing aids in the past six months.

The audiological assessment comprises pure tone audiometry, speech recognition audiometry, and sound field audiometry. The cognitive assessment includes the Mandarin version of the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). The emotional assessment consists of the 24-item Hamilton Depression Scale (HAMD) and the 15-item Geriatric Depression Scale (GDS). Sleep assessment is conducted using the Pittsburgh Sleep Quality Index (PSQI).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with ARHL
* Aged between 50 and 90
* Complete measuring data; including pure tone audiometry, speech audiometry, cognitive screening scales and resting-state electroencephalography
* Right-handed
* Regular daily use of hearing aid(s) for six-month period prior to the test date, or no hearing aid experience

Exclusion Criteria:

* Outer/middle ear abnormalities or any other central nervous system disorders

Primary outcomes:
measure: better-ear pure-tone averages (BEPTA)
timeFrame: Day1
measure: binaural averaged pure-tone averages (BAPTA)
timeFrame: Day1
measure: better-ear speech recognition thresholds (BESRT)
timeFrame: Day1
measure: binaural averaged speech recognition thresholds (BASRT)
timeFrame: Day1
measure: The global and subscores of the Mandarin version of the Montreal Cognitive Assessment (MoCA)
timeFrame: Day1
measure: The global and subscores of the Mandarin version of the Mini-Mental State Examination (MMSE)
timeFrame: Day1
Secondary outcomes:
measure: better-ear PTA in the aided condition (BEPTA-A)
timeFrame: Day1
measure: binaural averaged PTA in the aided condition (BAPTA-A)
timeFrame: Day1
measure: better-ear SRT in the aided condition (BESRT-A)
timeFrame: Day1
measure: binaural averaged SRT in the aided condition (BASRT-A)
timeFrame: Day1
measure: the global score of Pittsburgh sleep quality index (PSQI)
timeFrame: Day1
measure: the global score of Hamilton Depression Scale -24 items (HAMD-24)
timeFrame: Day1
measure: the global score of 15-item Geriatric Depression Scale (GDS-15)
timeFrame: Day1
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510000
state: Guangdong
Study officials:
affiliation: SunYatSunU2H
name: Haidi Yang, Prof.
role: STUDY_DIRECTOR
References: