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

NCT06495268 | Active Not Recruiting DMC

• 1 other identifier: KUH5551893
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sensorineural Hearing Loss; Cognitive Decline

Keywords

Hearing Impairment; Hearing Rehabilitation; Hearing Loss; Cognition; Data-driven rehabilitation

Outcome Measures

Primary Outcomes (2)

• Finnish Matrix Sentence Test (FMST)

  A Speech-in-Noise test, validated for the Finnish language. In the test participants will listen to five-word sentences chosen out of a standardized and optimized word matrix under stationary background noise (65dB SPL). The result of the FMST is the signal-to-noise ratio (SNR) at which the participant identifies 50% of the presented word items correctly, this is called the speech reception threshold (SRT50).

  Change measures: 0 months, 12 months, 24 months

• Digits in Noise test (DIN)

  A Speech-in-Noise test, validated for the Finnish language. The word material of the test consists of digit triplets presented under stationary background noise (65dB SPL). The result of the DIN is the signal-to-noise ratio at which the participant identifies 50% of the presented triplets correctly, this is called the speech reception threshold (SRT50).

  Change measures: 0 months, 12 months, 24 months

Secondary Outcomes (11)

• Speech, Spatial and Quality questionnaires - SSQ

  Change measures: 0 months, 12 months, 24 months

• Hearing aid usage (self-report and HAs log data)

  Change measures: 0 months, 12 months, 24 months

• Listening effort questionnaire

  Change measures: 0 months, 12 months, 24 months

• Response time (DIN test)

  Change measures: 0 months, 12 months, 24 months

• Tinnitus Handicap Inventory (THI)

  Change measures: 0 months, 12 months, 24 months

Other Outcomes (13)

• EEG-derived cortical auditory evoked potentials (CAEPs)

  Change measures: 0 months, 12 months, 24 months

• Structural MRI

  Change measures: 0 months, 12 months, 24 months

• Functional MRI

  Change measures: 0 months, 12 months, 24 months

Study Arms (2)

Individualised data-driven hearing rehabilitation

ACTIVE COMPARATOR

Participants in the intervention group will receive data-driven, regularly controlled hearing aid rehabilitation that is not part of the standard care protocol.

Other: Individualised data-driven hearing rehabilitation

Standard care hearing rehabilitation

ACTIVE COMPARATOR

The participants in the control group will receive the standard care HA rehabilitation currently conducted at the KUH Hearing Center.

Other: Standard care hearing rehabilitation

Interventions

Standard care hearing rehabilitation OTHER

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.

Standard care hearing rehabilitation

Individualised data-driven hearing rehabilitation OTHER

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.

Individualised data-driven hearing rehabilitation

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Related Publications (33)

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Related Links

• 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

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Cognitive Dysfunction; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Aarno Dietz, prof.

  Kuopio University Hospital and University of Eastern Finland

  PRINCIPAL INVESTIGATOR

• Alina Solomon, prof.

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: By default, hearing rehabilitators will be aware of which group of participants they are assigned to, since those assigned to the intervention group will need to implement a HA fitting protocol different from standard care. Participants will not be actively told which group they are assigned to following randomisation, although complete masking may not be feasible based on the differences between HA fitting protocols. Outcome assessors, the PI, co-PI, and other key project team members will be blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation) by computer-generated allocation in blocks of four (two individuals randomly allocated to each group). 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.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The trial Steering Committee and Management Group will consider applications for data after the trials results have been published and data will be made available according to the terms of the access agreement.
• Access Criteria: As described above in the Plan Description.

Locations

FI (1)