Can we do a study to prevent cognitive decline with hearing aids?
| ISRCTN | ISRCTN84550071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84550071 |
- Submission date
- 16/12/2021
- Registration date
- 09/09/2022
- Last edited
- 10/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Age-related hearing loss is responsible for about 90% of the hearing loss cases in adults. While it is easy to treat hearing loss with hearing aids, about one-third of the adults with hearing loss do not use hearing aids. It is unknown whether hearing improvement for those affected with hearing impairment will result in less cognitive decline (loss of mental abilities). Therefore we will conduct a study to see if it is possible to do a full scale trial assessing the effects of hearing aids on cognitive decline.
Who can participate?
People aged 65 years or older with hearing loss.
What does the study involve?
Participants will be randomized towards a group using hearing aids and a group not using hearing aids. All participants will complete study questionnaires and cognitive tests.
What are the possible benefits and risks of participating?
Benefits: some participants who would not have otherwise sought out treatment with a hearing aid will have one provided
Risks: none
Where is the study run from?
UMC Utrecht (Netherlands)
When is the study starting and how long is it expected to run for?
January 2022 to July 2024
Who is funding the study?
ZonMW (Netherlands)
Who is the main contact?
Dr Stegeman
i.stegeman@umcutrecht.nl
Contact information
Scientific
Heidelberglaan 100
Room G05.129
Utrecht
3508AB
Netherlands
 ORCID ID |
0000-0001-9326-6702 |
|---|---|
| Phone | +31 88 75 57564 |
| d.fuchten@umcutrecht.nl |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Feasibility study for a randomized controlled trial to evaluate the effect of hearing aids on cognitive decline in elderly individuals: Cognition and Isolation in Deafness |
| Study acronym | CognID |
| Study hypothesis | Feasibility of an RCT investigating the effect of hearing aids on cognitive decline |
| Ethics approval(s) | Approved 01/08/2022 (Medical Research Ethics Committee NedMec (MREC NedMec)) ref:22-697/H-A Amendment approved on 25/01/2023 |
| Condition | Cognitive decline |
| Intervention | Current interventions as of 28/02/2023: After informed consent of eligible patients, participants will be randomly allocated to one of the two groups; the hearing aid group or the control group. Randomisation will take place by the study management system Castor. Investigators will be blinded of the randomisation sequence. After randomisation, an appointment will be made for an in house-visit or visit to the clinic in order to assess the cognitive functioning of the participants. After the visit, participants randomized to the intervention group will be referred to a local hearing aid centre to collect and adjust a standard of care hearing aid (no type and brand restrictions) uni- or bilateral. Participants randomized to the control group will continue without a hearing aid. Six months after inclusion of participants a second visit will be performed by a similar procedure as the first visit to fulfil the test battery again whereafter the study stops. _____ Previous interventions: After informed consent of eligible patients, participants will be randomly allocated to one of the two groups; the hearing aid group or the control group. Randomisation will take place by the study management system Castor. Investigators will be blinded of the randomisation sequence. After randomisation, an appointment will be made for an in house-visit or visit to the clinic in order to assess the cognitive functioning of the participants. Two weeks before this visit participants are asked by email to fill out digital questionnaires. If participants are unable to answer the questionnaires digitally, paper versions will be filled out by the participant during the visit. After the visit, participants randomized to the intervention group will be referred to a local hearing aid centre to collect and adjust a standard of care hearing aid (no type and brand restrictions) uni- or bilateral. Participants randomized to the control group will continue without a hearing aid. Six months after inclusion of participants a second visit will be performed by a similar procedure as the first visit to fulfil the test battery again whereafter the study stops. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Standard of care hearing aid (no type and brand restrictions) |
| Primary outcome measure | 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 | 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. 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. |
| Overall study start date | 15/01/2022 |
| Overall study end date | 17/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 24 |
| Participant 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. _____ 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 |
| Participant exclusion criteria | 1. Severe cognitive impairment before the start of the study 2. Don’t speak the Dutch language |
| Recruitment start date | 22/08/2022 |
| Recruitment end date | 17/07/2024 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Utrecht
3584 CX
Netherlands
Sponsor information
Hospital/treatment centre
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 612435610 |
|---|---|
| DHS-datamanagement@umcutrecht.nl | |
| Website | http://www.umcutrecht.nl/nl/ |
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 28/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Outcomes will be submitted to open access journals |
| IPD sharing plan | Data will be shared upon request to Dr. Inge Stegeman. i.stegeman@umcutrecht.nl |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 27/12/2023 | 27/12/2023 | Yes | No |
Editorial Notes
10/04/2025: The following changes have been made:
1. The overall study end date has been changed from 28/12/2024 to 17/07/2024.
2. The recruitment end date has been changed from 31/08/2024 to 17/07/2024.
3. The intention to publish date has been changed from 28/02/2025 to 28/02/2026.
27/12/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2023 to 31/08/2024.
2. The overall study end date has been changed from 31/12/2023 to 28/12/2024 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/12/2023 to 28/02/2025.
4. Publication reference added.
27/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/02/2023 to 31/08/2023.
2. The overall end date was changed from 28/02/2023 to 31/12/2023.
3. The intention to publish date was changed from 15/03/2023 to 31/12/2023.
4. The scientific title was changed from "Feasibility study for a randomized controlled trial to evaluate the effect of hearing aids on cognitive decline in vulnerable patients: Cognition and Isolation in Deafness" to "Feasibility study for a randomized controlled trial to evaluate the effect of hearing aids on cognitive decline in elderly individuals: Cognition and Isolation in Deafness".
5. The inclusion criteria were changed.
6. The ethics approval was added.
7. The plain English summary was updated to reflect these changes.
13/10/2022: The contact details were updated.
04/08/2022: Trial's existence confirmed by NedMec.
