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A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids

Primary Purpose

Age-related Hearing Loss, Hearing Loss, Sensorineural, Hearing Aid

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hearing Aids
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Hearing Loss

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age>60yrs,≤85yrs(MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79,and25.2% for80-84); Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL, and the PTA ≤ 90 dB HL; Diagnosed as Presbycusis; Score of 23 or below on Mini-Mental Status Exam (MMSE); Score of 22 or below on Montreal Cognitive Assessment (MoCA); Exclusion Criteria: Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss); Significant history of otologic or neurologic disorders; Hearing loss remediated with a cochlear implant (cannot wear hearing aids); Any clinically significant unstable or progressive medical condition; Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.

Sites / Locations

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Intervention Group

Arm Description

Procedure: no intervention

Procedure: a intervention via hearing aids for 5 years

Outcomes

Primary Outcome Measures

MoCA
Montreal Cognitive Assessment is an assessment tool for rapid screening of cognitive dysfunction.
MMSE
Mini-mental State Examination is currently the preferred scale for cognitive impairment screening and is widely used in dementia screening.

Secondary Outcome Measures

Pure Tone Audiometry
Pure audiometry is to measure the air conduction hearing thresholds of 125Hz, 250Hz, 500Hz, 1000Hz, 2000Hz, 4000Hz and 8000Hz and bone conduction threshold of 500Hz, 1000Hz, 2000Hz and 4000Hz in normal people and deaf patients by Hughson-Westlake(HW) method, also gets the tested person's pure-tone average (PTA) in the hearing ear which is calculated using thresholds for 0.5, 1, 2 and 4 kHz. The acoustic standard of the sound insulation room is GB/T16296, the reverberation time is (0.3±0.15) seconds, and the pure tone audiometer model is Interacoustics AC40(Inter-c AC40).
Speeeh Audlometry
Speech audiometry is a kind of audiometry method that uses standardized speech signals as sound stimulation to test the speech recognition ability of subjects.

Full Information

First Posted
January 12, 2023
Last Updated
January 20, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05694039
Brief Title
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
Official Title
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
March 9, 2028 (Anticipated)
Study Completion Date
March 9, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Deafness is one of the nine potentially modifiable risk factors for dementia simulated by the Lancet dementia Prevention, intervention and Care Committee in 2017. Some studies have found that the risk factors of dementia in deafness system, with the increase of the degree of deafness, the risk of cognitive decline increases, while after long-term wear of hearing aids, the deterioration of immediate and delayed memory is less, and the possibility of cognitive decline slows down. Therefore, it is necessary for us to improve the auditory ability of patients with deafness through auditory intervention, so as to slow down its effect on dementia and reduce the incidence of dementia. At present, auditory intervention methods include hearing aid wearing and cochlear implant. However, there are few studies on cognitive function of presbycusis patients in China, and there is no research on how many years of auditory intervention can effectively slow down the incidence of dementia in presbycusis patients with MCI. Therefore, we intend to conduct a prospective cohort study on the changes of cognitive function of presbycusis under hearing aid intervention.
Detailed Description
Materials and methods: The unicentric, prospective cohort study included 388 patients with presbycusis aged 60-85 who were recruited in the Department of Otorhinolaryngology from March 2022 to March 2028. They were averagely divided into the control group (n = 194) and the intervention group (n = 194). The post intervention group received hearing aid intervention, and was followed up for 5 years, once every six months. Audiological assessment, cognitive function assessment, noninvasive brain imaging assessment and hearing aid effect assessment were performed at baseline and each follow-up. This thesis aim to investigate the changes of cognitive function in senile deafness under the intervention of hearing aids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Hearing Loss, Hearing Loss, Sensorineural, Hearing Aid, Cognitive Function Abnormal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Procedure: no intervention
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Procedure: a intervention via hearing aids for 5 years
Intervention Type
Device
Intervention Name(s)
Hearing Aids
Intervention Description
The intervention group uses hearing aids, and the intervention group receives hearing aid intervention for 5 years.
Primary Outcome Measure Information:
Title
MoCA
Description
Montreal Cognitive Assessment is an assessment tool for rapid screening of cognitive dysfunction.
Time Frame
half a year
Title
MMSE
Description
Mini-mental State Examination is currently the preferred scale for cognitive impairment screening and is widely used in dementia screening.
Time Frame
half a year
Secondary Outcome Measure Information:
Title
Pure Tone Audiometry
Description
Pure audiometry is to measure the air conduction hearing thresholds of 125Hz, 250Hz, 500Hz, 1000Hz, 2000Hz, 4000Hz and 8000Hz and bone conduction threshold of 500Hz, 1000Hz, 2000Hz and 4000Hz in normal people and deaf patients by Hughson-Westlake(HW) method, also gets the tested person's pure-tone average (PTA) in the hearing ear which is calculated using thresholds for 0.5, 1, 2 and 4 kHz. The acoustic standard of the sound insulation room is GB/T16296, the reverberation time is (0.3±0.15) seconds, and the pure tone audiometer model is Interacoustics AC40(Inter-c AC40).
Time Frame
half a year
Title
Speeeh Audlometry
Description
Speech audiometry is a kind of audiometry method that uses standardized speech signals as sound stimulation to test the speech recognition ability of subjects.
Time Frame
half a year
Other Pre-specified Outcome Measures:
Title
EEG/ERP
Description
Electroencephalograph ( EEG power in alpha band) is record which reflects regular electric action of brain cells groups by the 128-channel EEG analyzer of EGI Company, USA, with its matching electrode cap, of which transverse axis represents time, and vertical y-axis represents value of potential generated by brain cells.
Time Frame
half a year
Title
fNIRS
Description
Functional Near Infrared Spectroscopy uses fNIRS signal to measure the magnetic changes caused by the change of hemoglobin concentration in the process of brain cognitive activity at the level of brain imaging, so as to obtain BOLD signal.
Time Frame
half a year
Title
Hearing Aid Assessment composite
Description
The assessment of hearing aid effect includes Chinese Version Hearing Handicap Inventory for the Elderly Screening(CHHIE-S), Abbreviated Profile of Hearing Aid Benefit(APHAB), Satisfaction with Amplification in DailyLife(SADL) and International Outcome Items for Hearing Aids(IOI-HA).
Time Frame
half a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age>60yrs,≤85yrs(MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79,and25.2% for80-84); Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL, and the PTA ≤ 90 dB HL; Diagnosed as Presbycusis; Score of 23 or below on Mini-Mental Status Exam (MMSE); Score of 22 or below on Montreal Cognitive Assessment (MoCA); Exclusion Criteria: Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss); Significant history of otologic or neurologic disorders; Hearing loss remediated with a cochlear implant (cannot wear hearing aids); Any clinically significant unstable or progressive medical condition; Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minqian Gao, B.sc
Phone
13660778861
Email
gaomq6@mail.sysu.edu.cn
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minqian Gao, B.sc
Phone
13660778861
Email
gaomq6@mail.sysu.edu.cn

12. IPD Sharing Statement

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A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids

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