Data-driven hearing rehabilitation for healthy aging
Healthy Hearing for Healthy Ageing: a Proof-of-concept Randomized Controlled Trial of Data-driven Hearing Rehabilitation Versus Standard Care in Older Adults with Hearing Impairment.
This study is testing a new personalized hearing rehab program to see if it helps older adults with mild to moderate hearing loss hear better and improve their quality of life compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years to 84 Years |
| Sex | All |
| Sponsor | Kuopio University Hospital Academic / other |
| Locations | 1 site (Kuopio) |
| Trial ID | NCT06495268 on ClinicalTrials.gov |
What this trial studies
The HAHA trial aims to evaluate the effectiveness of an individualized, data-driven hearing rehabilitation protocol compared to standard care in older adults with mild to moderate sensorineural hearing loss. Participants will be randomized to receive either the new intervention or standard care, with a focus on improving speech perception in noise, cognitive function, and overall quality of life. The study will recruit 200 community-dwelling individuals aged 65 to 84 who are first-time hearing aid users and will follow them for 12 months with additional monitoring appointments. This pragmatic approach seeks to optimize the current clinical pathway for hearing rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling individuals aged 65 to 84 with mild to moderately severe sensorineural hearing loss who are first-time hearing aid users.
Not a fit: Patients with conductive hearing loss, significant differences in hearing levels between ears, or those with previously diagnosed dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve hearing, cognitive function, and quality of life for older adults with hearing impairment.
How similar studies have performed: While the approach is innovative, it builds on ongoing research, suggesting potential for success based on preliminary findings from related studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Kuopio
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
Study contacts
- Principal investigator: Aarno Dietz, prof. — Kuopio University Hospital and University of Eastern Finland
- Study coordinator: Laura Ihalainen, MD
- Email: laura.ihalainen@pshyvinvointialue.fi
- Phone: +358447176801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.