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Active, not recruiting Observational

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

NCT06893432 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-12-01
Last updated
2025-03-25

Condition(s) studied

Age-related Hearing LossAge-related Cognitive DeclineDepressionSleep Disturbance

Investigational drug(s) / intervention(s)

hearing aids

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.

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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.
  • 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 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.
  • 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.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510000 Guangzhou Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06893432 on ClinicalTrials.gov ↗ ← All trials in China