Healthy HeaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing
NCT ID: NCT06495268
Last Updated: 2024-11-22
Study Results
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Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-10-01
2027-10-30
Brief Summary
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Participants will be randomized 1:1 to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation). The primary objective of this study is to investigate the effect of an optimized data-driven hearing rehabilitation protocol versus standard care protocol on change in speech perception in noise (SPIN) in older adults with mild to moderately severe sensorineural HI and without dementia.
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Detailed Description
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The HAHA trial will test an individualised, data-driven hearing rehabilitation protocol based on the ongoing BREM (Benefits of Real-Ear Measurement) study at KUH (clinicaltrials.gov ID NCT05621798). HAHA will use a pragmatic approach incorporated into routine specialized care (Hearing Center at the Dept of Otorhinolaryngology of KUH), to facilitate optimisation of the current HI clinical pathway and treatment process. This study is a proof-of-concept, single-site, 2-arm parallel group 12-month randomized controlled trial with a 12-month extended follow-up.
The investigators will recruite 200 participants referred to the Kuopio University Hospital Hearing Center from primary care that are aged 65 to 84 years with mild to moderately severe sensorineural HI and are about to receive their first HAs.
The intervention group will receive individually fitted HAs based on preliminary results from the ongoing BREM study at KUH to ensure adequate amplification, with immediate SPIN-based benefit validation. HA selection and individual tailoring will also be based on hearing questionnaires data. Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting.
The control group will receive the same HAs fitted according to the standard care protocol. Standard care follow-up includes a phone call check 3 months after the primary fitting. Additional monitoring/re-fitting may be offered based on the participant's feedback and hearing rehabilitator's clinical judgement.
A range of auditory, cognitive, quality of life and psychosocial measures as well as exploratory measures such as EEG, MRI and vision-related measures are assessed at 12-month and 24-month visits on both groups. These assessments are included to investigate potential mechanisms underlying associations between HI, hearing rehabilitation, vision and cognition. The overall duration of the this trial is 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The intervention group will receive individually fitted HAs with immediate SPIN-based benefit validation. HA selection and individual tailoring will also be based on hearing questionnaires data. Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months.
The control group will receive the same HAs fitted according to the standard care protocol. Standard care follow-up includes a phone call check 3 months after the primary fitting. Additional monitoring/re-fitting may be offered based on the participant's feedback and hearing rehabilitator's clinical judgement.
12-month and 24-months follow-up appointments are arranged for both groups.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Individualised data-driven hearing rehabilitation
Participants in the intervention group will receive data-driven, regularly controlled hearing aid rehabilitation that is not part of the standard care protocol.
Individualised data-driven hearing rehabilitation
HA fittings will be conducted with the Real-Ear Measurements (REM) method that is recommended by the latest ISO-standard (21388:2020) and by the preliminary results of the BREM study at KUH. After the fitting of the HAs, participants' auditory-related outcomes will be immediately assessed using DigiKuulo and re-fitting is performed if needed based on the following criteria:
1. The absolute improvement in the DIN test is less than 1,5dB (SNR), OR
2. The absolute result of the DIN test is more than -8,5 dB (SNR) OR
3. The participant is unsatisfied with the HA fitting
Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting. At these visits, auditory outcomes of the rehabilitation are assessed via DigiKuulo and re-fittings are performed as needed.
Standard care hearing rehabilitation
The participants in the control group will receive the standard care HA rehabilitation currently conducted at the KUH Hearing Center.
Standard care hearing rehabilitation
HA will be fitted with automatic algorithms by HA manufacturers and REM-fitting is only applied in complex cases based on the hearing rehabilitator's clinical judgement. Three months after the HA fitting, participants will be contacted via phone call to inquire about the status of the rehabilitation. Additional monitoring visits may be offered based on the participant's feedback. After the 3-month monitoring phone call participants will be advised to further contact the study team if they are dissatisfied with the amplification or for any other problem with their device.
Interventions
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Individualised data-driven hearing rehabilitation
HA fittings will be conducted with the Real-Ear Measurements (REM) method that is recommended by the latest ISO-standard (21388:2020) and by the preliminary results of the BREM study at KUH. After the fitting of the HAs, participants' auditory-related outcomes will be immediately assessed using DigiKuulo and re-fitting is performed if needed based on the following criteria:
1. The absolute improvement in the DIN test is less than 1,5dB (SNR), OR
2. The absolute result of the DIN test is more than -8,5 dB (SNR) OR
3. The participant is unsatisfied with the HA fitting
Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting. At these visits, auditory outcomes of the rehabilitation are assessed via DigiKuulo and re-fittings are performed as needed.
Standard care hearing rehabilitation
HA will be fitted with automatic algorithms by HA manufacturers and REM-fitting is only applied in complex cases based on the hearing rehabilitator's clinical judgement. Three months after the HA fitting, participants will be contacted via phone call to inquire about the status of the rehabilitation. Additional monitoring visits may be offered based on the participant's feedback. After the 3-month monitoring phone call participants will be advised to further contact the study team if they are dissatisfied with the amplification or for any other problem with their device.
Eligibility Criteria
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Inclusion Criteria
* Community-dwelling, i.e. living at home / not living in a care home or nursing home
* Proficiency in Finnish language
* First-time hearing aid user
Exclusion Criteria
* Difference between hearing levels of the ears is more than 15dB (HL) in three consecutive frequencies
* Hearing aid contraindication
* Previously diagnosed dementia, or current use of cholinesterase inhibitors and/or memantine. If there is a current ongoing diagnostic process for suspected dementia, the decision on eligibility will be made by an experienced study physician based on medical records and clinical judgement.
* Any health conditions severely impairing vision, mobility, communication, and/or ability to participate in study visits and complete study assessments, as judged by the study nurse and/or physician.
65 Years
84 Years
ALL
No
Sponsors
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University of Eastern Finland
OTHER
Kuopio University Hospital
OTHER
Responsible Party
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Principal Investigators
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Aarno Dietz, prof.
Role: PRINCIPAL_INVESTIGATOR
Kuopio University Hospital and University of Eastern Finland
Alina Solomon, prof.
Role: PRINCIPAL_INVESTIGATOR
University of Eastern Finland
Locations
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Kuopio University Hospital
Kuopio, , Finland
Countries
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Central Contacts
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Facility Contacts
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Aarno Dietz, prof.
Role: backup
Alina Solomon, prof.
Role: backup
Laura Ihalainen, MD
Role: backup
Petteri Hyvärinen, DSc
Role: backup
Pia Linder, PhD
Role: backup
References
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Related Links
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WORLD REPORT ON HEARING
Development of the "Hearing In Real-Life Environments" Questionnaire
Methods for Analysing and Reporting EQ-5D Data \[Internet\]. Cham (CH): Springer; 2020. Chapter 1, An Introduction to EQ-5D Instruments and Their Applications
Other Identifiers
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KUH5551893
Identifier Type: -
Identifier Source: org_study_id
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