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

NCT06893432 | Active Not Recruiting

• 1 other identifier: SYSKY-2024-938-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Hearing Loss; Age-related Cognitive Decline; Depression; Sleep Disturbance

Keywords

age-related hearing loss; cognition; electroencephalogram

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• better-ear PTA in the aided condition (BEPTA-A)

  Day1

• binaural averaged PTA in the aided condition (BAPTA-A)

  Day1

• better-ear SRT in the aided condition (BESRT-A)

  Day1

• binaural averaged SRT in the aided condition (BASRT-A)

  Day1

• the global score of Pittsburgh sleep quality index (PSQI)

  Day1

Study Arms (2)

Aided

Participants who have regularly used hearing aid(s) to improve hearing during the past six-month period.

Device: hearing aids

Control

Participants without any experience of using hearing aids.

Interventions

hearing aids DEVICE

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.

Aided

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Presbycusis; Depression; Parasomnias

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Haidi Yang, Prof.

  SunYatSunU2H

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 25, 2025
• Study Start: December 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 25, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)