Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing

Last updated: March 2, 2026
Sponsor: Kuopio University Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Hearing Loss

Hearing Impairment

Treatment

Standard care hearing rehabilitation

Individualised data-driven hearing rehabilitation

Clinical Study ID

NCT06495268
KUH5551893
  • Ages 65-84
  • All Genders

Study 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 with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised data-driven protocol for early hearing rehabilitation. The main hypothesis is that, compared with standard care, the data-driven rehabilitation will likely have broader benefits manifested in three key areas: hearing, cognition, and quality of life and psychosocial outcomes.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Mild to moderately severe sensorineural HI (PTA (0,5-4kHz) between 20-64 dB (HL), asper 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

Exclusion Criteria:

  • Conductive hearing loss (air-bone gap more than 20 dB HL in two consecutivefrequencies)

  • Difference between hearing levels of the ears is more than 15dB (HL) in threeconsecutive frequencies

  • Hearing aid contraindication

  • Previously diagnosed dementia, or current use of cholinesterase inhibitors and/ormemantine. If there is a current ongoing diagnostic process for suspected dementia,the decision on eligibility will be made by an experienced study physician based onmedical records and clinical judgement.

  • Any health conditions severely impairing vision, mobility, communication, and/orability to participate in study visits and complete study assessments, as judged bythe study nurse and/or physician.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Standard care hearing rehabilitation
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
February 29, 2028

Study 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 dementia risk reduction, although a causal HI-dementia relation is not fully established.

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.

Connect with a study center

  • Kuopio University Hospital

    Kuopio, 70210
    Finland

    Site Not Available

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