Status:
RECRUITING
Healthy HeaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing
Lead Sponsor:
Kuopio University Hospital
Collaborating Sponsors:
University of Eastern Finland
Conditions:
Sensorineural Hearing Loss
Cognitive Decline
Eligibility:
All Genders
65-84 years
Phase:
NA
Brief Summary
The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity...
Detailed Description
Hearing impairment (HI) is a major public health problem. HI has also been identified as a significant potentially modifiable risk factor for dementia. Thus, hearing rehabilitation may contribute to d...
Eligibility Criteria
Inclusion
- Mild to moderately severe sensorineural HI (PTA (0,5-4kHz) between 20-64 dB (HL), as per Global Burden of Disease Expert Group on Hearing loss 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
- Conductive hearing loss (air-bone gap more than 20 dB HL in two consecutive frequencies)
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06495268
Start Date
October 1 2024
End Date
October 30 2027
Last Update
November 22 2024
Active Locations (1)
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1
Kuopio University Hospital
Kuopio, Finland, 70210