Can we do a study to prevent cognitive decline with hearing aids?

Not Applicable

• Conditions: Cognitive decline; Mental and Behavioural Disorders

• Registration Number: ISRCTN84550071
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-074176 (added 27/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-09
• Last Update Posted: 8 January 2024
• Study Completion: 2024-12-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Current inclusion criteria as of 27/02/2023:

1. 65 years and older at the time of consent
2. =35-<50 dB PTA hearing loss (0.5-4 kHz) uni- or bilateral, as assessed in a recent (less than 6 months old) hearing examination
3. Not using a hearing aid at time of assessment
4. No foreseen surgcal interventions to restore hearing planned during the time of the study follow-up.

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Previous inclusion criteria:

1. 65 years and older
2. =35-<50 dB PTA hearing loss (0.5-4 kHz) uni- or bilateral, without using a hearing aid at time of assessment and without foreseen surgical interventions to restore hearing planned during the time of the study follow-up.
3. Hearing examination performed in an audiological centre less than 6 months ago

Exclusion Criteria

1. Severe cognitive impairment before the start of the study
2. Don’t speak the Dutch language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The willingness of ‘naïve’ patients to be randomized for hearing amplification in a study concerning cognition. Reasons for refusing to take part in the study will be noted. Based on the resulting number and percentage of eligible patients willing to be randomized we will assess the feasibility to include the intended number of participants for the main CognID study from hearing centers.

Secondary Outcome Measures

Name	Time	Method
1. Feasibility of the test battery for cognitive tests, at baseline and 6 months. Missing data for each outcome measure will be analysed, and reasons for these missing data will be assessed. The number of tests included in the test battery will be reconsidered according to the amount of missing data, retention and dropout rate and reasons for withdrawal/non-completion.<br>2. Therapy compliance of hearing aid use for individuals willing to be randomized in a RCT. Adherence to the intervention will be noted. The threshold for adherence to hearing aid use will be set to four hours a day and at least four days of usage during the week.