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

Active, not recruiting

• Conditions: Age-related Hearing Loss; Age-related Cognitive Decline; Depression; Sleep Disturbance

• Registration Number: NCT06893432
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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).

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12-01
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
better-ear pure-tone averages (BEPTA)	Day1	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.
binaural averaged pure-tone averages (BAPTA)	Day1	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.
The global and subscores of the Mandarin version of the Montreal Cognitive Assessment (MoCA)	Day1	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.
better-ear speech recognition thresholds (BESRT)	Day1	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.
binaural averaged speech recognition thresholds (BASRT)	Day1	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.
The global and subscores of the Mandarin version of the Mini-Mental State Examination (MMSE)	Day1	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.

Secondary Outcome Measures

Name	Time	Method
binaural averaged SRT in the aided condition (BASRT-A)	Day1	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.
better-ear PTA in the aided condition (BEPTA-A)	Day1	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.
binaural averaged PTA in the aided condition (BAPTA-A)	Day1	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.
better-ear SRT in the aided condition (BESRT-A)	Day1	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.
the global score of Pittsburgh sleep quality index (PSQI)	Day1	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.
the global score of Hamilton Depression Scale -24 items (HAMD-24)	Day1	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.
the global score of 15-item Geriatric Depression Scale (GDS-15)	Day1	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.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510000; 🇨🇳 Guangzhou, Guangdong, China