Cognitive Function and EEG Brain Network Remodeling Among Users of Hearing Aids With ARHL (EEG/ARHL)

Cognitive Function and Electroencephalogram Brain Network Remodeling Among Users of Hearing Aids With Age-Related Hearing Loss

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Sleep Disturbance; Age-related Cognitive Decline; Age-related Hearing Loss
• Intervention / Treatment: Device: hearing aids

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).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aided; Participants who have regularly used hearing aid(s) to improve hearing during the past six-month period.	Device: hearing aids; Hearing aids are a common intervention method used to address age-related hearing loss, providing amplified sound to improve hearing clarity and communication abilities for elderly individuals.
Control; Participants without any experience of using hearing aids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
better-ear pure-tone averages (BEPTA)	The pure-tone thresholds were tested using a Piano Plus diagnostic audiometer (Inventis, Italy), following the standard Hughson-Westlake method (i.e., up 5 and down 10 dB HL). Subsequently, the pure tone average (PTA) of air conduction thresholds between 500 and 4000 Hz was calculated ear by ear. Better-ear PTA of each participant will be collected for further analysis.	Day1
binaural averaged pure-tone averages (BAPTA)	The pure-tone thresholds were tested using a Piano Plus diagnostic audiometer (Inventis, Italy), following the standard Hughson-Westlake method (i.e., up 5 and down 10 dB HL). Subsequently, the pure tone average (PTA) of air conduction thresholds between 500 and 4000 Hz was calculated ear by ear. binaural averaged PTA of each participant will be collected for further analysis.	Day1
better-ear speech recognition thresholds (BESRT)	Speech recognition audiometry was tested using a Piano Plus diagnostic audiometer and a Chinese disyllabic version of speech material. The correct recognition rate at each 10 dB step of test intensity was recorded, covering the full range from 0% to 100% as much as possible. However, the intensity would cease increasing when it reached the maximum tolerable limit for the participant or the maximum output of the equipment. Specifically, speech recognition threshold (SRT) was defined as the signal intensity required for the test ear to achieve a 50% correct recognition rate. Better-ear SRT of each participant will be collected for further analysis.	Day1
binaural averaged speech recognition thresholds (BASRT)	Speech recognition audiometry was tested using a Piano Plus diagnostic audiometer and a Chinese disyllabic version of speech material. The correct recognition rate at each 10 dB step of test intensity was recorded, covering the full range from 0% to 100% as much as possible. However, the intensity would cease increasing when it reached the maximum tolerable limit for the participant or the maximum output of the equipment. Specifically, speech recognition threshold (SRT) was defined as the signal intensity required for the test ear to achieve a 50% correct recognition rate. binaural averaged SRT of each participant will be collected for further analysis.	Day1
The global and subscores of the Mandarin version of the Montreal Cognitive Assessment (MoCA)	MoCA consists of seven subcomponents, namely visual-spatial function, naming, attention, language, abstraction, delayed recall, and orientation. It scores based on whether participants answer each item correctly, with a total score of 30. A higher score indicates better cognitive function.	Day1
The global and subscores of the Mandarin version of the Mini-Mental State Examination (MMSE)	MMSE comprises six components: temporal orientation, spatial orientation, immediate memory, attention and calculation abilities, delayed memory, and language ability. Depending on participants' accuracy in answering each test item, MMSE is scored out of 30 points. A higher score indicates better cognitive function.	Day1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
better-ear PTA in the aided condition (BEPTA-A)	For the aided group, participants additionally underwent a sound field audiometry (hearing thresholds ) with their hearing aid(s) on. The stimuli were presented through two binaural speakers placed one meter from the participants at 45° azimuth via a Piano Plus diagnostic audiometer. During the test session, participants were seated in an upright position to ensure the height of the microphone(s) on their hearing aid(s) was consistent with the height of the geometric center of the speaker(s). Similarly, their better-ear PTA (BEPTA-A) in the aided condition will be collected for further analysis.	Day1
binaural averaged PTA in the aided condition (BAPTA-A)	For the aided group, participants additionally underwent a sound field audiometry (hearing thresholds ) with their hearing aid(s) on. The stimuli were presented through two binaural speakers placed one meter from the participants at 45° azimuth via a Piano Plus diagnostic audiometer. During the test session, participants were seated in an upright position to ensure the height of the microphone(s) on their hearing aid(s) was consistent with the height of the geometric center of the speaker(s). Similarly, their binaural averaged PTA (BAPTA-A) in the aided condition will be collected for further analysis.	Day1
better-ear SRT in the aided condition (BESRT-A)	For the aided group, participants additionally underwent a sound field audiometry (hearing thresholds ) with their hearing aid(s) on. The stimuli were presented through two binaural speakers placed one meter from the participants at 45° azimuth via a Piano Plus diagnostic audiometer. During the test session, participants were seated in an upright position to ensure the height of the microphone(s) on their hearing aid(s) was consistent with the height of the geometric center of the speaker(s). Similarly, their better-ear SRT (BESRT-A) in the aided condition will be collected for further analysis.	Day1
binaural averaged SRT in the aided condition (BASRT-A)	For the aided group, participants additionally underwent a sound field audiometry (hearing thresholds ) with their hearing aid(s) on. The stimuli were presented through two binaural speakers placed one meter from the participants at 45° azimuth via a Piano Plus diagnostic audiometer. During the test session, participants were seated in an upright position to ensure the height of the microphone(s) on their hearing aid(s) was consistent with the height of the geometric center of the speaker(s). Similarly, their binaural averaged SRT (BASRT-A) in the aided condition will be collected for further analysis.	Day1
the global score of Pittsburgh sleep quality index (PSQI)	PSQI scale was compiled by Buysse et al in 1989 to assess the sleep quality of individuals in the last 1 month. The total score ranges from 0 to 21. A higher score indicates worse sleep quality in the past month.	Day1
the global score of Hamilton Depression Scale -24 items (HAMD-24)	The HAMD-24 was used to assess the degree of depression and emotional state in patients with chronic subjective tinnitus. The assessment included the emotional state and symptoms of autonomic nervous system disorders in the past week, and each question was scored according to the presence and severity of symptoms. The total score ranges from 0 to 76. A higher score indicates worse emotion state in the past week.	Day1
the global score of 15-item Geriatric Depression Scale (GDS-15)	GDS-15 is a self-rated depression questionnaire, with higher scores indicating a worse depressive state. The total score ranges from 0 to 15. A higher score indicates worse emotion state in the past week.	Day1

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Director: Haidi Yang, Prof., SunYatSunU2H

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: cognition; electroencephalogram; age-related hearing loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss, Sensorineural; Cognitive Dysfunction; Hearing Loss; Deafness; Presbycusis
• Other Study ID Numbers: SYSKY-2024-938-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No