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

Browse trials for

• Presbycusis 66
• Depression 8,577

Keywords

• age-related hearing loss
• cognition
• electroencephalogram

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's planned enrollment of 60 is below the median of 123 across 20 observational studies indexed under Presbycusis.

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.

Study population

Groups and cohorts

• 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

• Devicehearing 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.

Primary outcomes

1. 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.

   Time frame: Day1

2. 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.

   Time frame: Day1

3. 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.

   Time frame: Day1

4. 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.

   Time frame: Day1

5. 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.

   Time frame: Day1

6. 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.

   Time frame: Day1

Secondary outcomes

1. 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.

   Time frame: Day1

2. 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.

   Time frame: Day1

3. 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.

   Time frame: Day1

4. 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.

   Time frame: Day1

5. 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.

   Time frame: Day1

6. 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.

   Time frame: Day1

7. 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.

   Time frame: Day1

Individual participant data

Plan to share: No