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NCT Number: NCT06495268

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • The absolute improvement in the DIN test is less than 1,5dB (SNR), OR
  • The absolute result of the DIN test is more than -8,5 dB (SNR) OR
  • 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

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.

Primary outcomes

  1. Finnish Matrix Sentence Test (FMST)

    Time frame: Change measures: 0 months, 12 months, 24 months

    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).

  2. Digits in Noise test (DIN)

    Time frame: Change measures: 0 months, 12 months, 24 months

    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).

Secondary outcomes

  1. Speech, Spatial and Quality questionnaires - SSQ

    Time frame: Change measures: 0 months, 12 months, 24 months

    The SSQ questionnaire is a self-reporting hearing questionnaire that comprises 49 questions divided into three subdomains: Speech Perception (SP), Spatial Hearing (SH) and other qualities of Hearing (SQ) (18). The answers are provided on an 11-point Likert scale, ranging from 0 to 10.

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

    Time frame: Change measures: 0 months, 12 months, 24 months

    Usage rates of HAs (hours per day) are regularly checked via the HAs' log-data source and recorded during every clinical visit. In addition, participants' own estimation of usage rates is inquired and recorded.

  3. Listening effort questionnaire

    Time frame: Change measures: 0 months, 12 months, 24 months

    Listening effort will be self-reported by the participant for listening tasks of varying difficulties (i.e., different signal-to-noise ratios) on a 10-point VAS scale.

  4. Response time (DIN test)

    Time frame: Change measures: 0 months, 12 months, 24 months

    Response time for the answers given by the participant will be calculated and recorded automatically

  5. Tinnitus Handicap Inventory (THI)

    Time frame: Change measures: 0 months, 12 months, 24 months

    The THI is a 25-item self-report questionnaire for tinnitus that has Functional, Emotional and Catastrophic subscales. It has excellent convergent validity, construct validity and test-retest reliability. The THI takes 10min to complete. Scoring takes 5 min with a score of 4 for a 'yes', 2 for 'sometimes' and 0 for 'no'.

  6. CERAD-nb (global and domain scores)

    Time frame: Change measures: 0 months, 12 months, 24 months

    The Finnish version of the CERAD (Consortium to Establish a Registry for Alzheimer´s Disease) test battery is recommended for assessment of memory disorders in the national Current Care Guidelines developed by the Finnish Medical Society Duodecim (www.kaypahoito.fi).

  7. Clinical Dementia Rating Sum of Boxes (CDR-SoB)

    Time frame: Change measures: 0 months, 12 months, 24 months

    CDR (Clinical Dementia Rating) is used to assess the influence of cognitive impairment on the ability to conduct everyday activities in people with AD and gives a global clinical impression of the functioning level of the study participant. The assessor will interview the participant regarding their cognitive performance on six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on level of impairment: 0 (none), 0.5 (questionable), 1 (mild dementia), 2 (moderate dementia) or 3 (severe dementia). The total Sum of Boxes ranges from 0 (no impairment) to 18 (severe impairment on all domains).

  8. 15D questionnaire

    Time frame: Change measures: 0 months, 12 months, 24 months

    A generic, comprehensive, standardized, self-administered questionnaire of health-related quality of life developed in Finland. It includes 15 questions providing a numerical score for patient-perceived health status. It can be used both as a profile and single index score measure. It is commonly used in Finland to assess quality of life in standard care.

  9. EQ5-D-5L questionnaire

    Time frame: Change measures: 0 months, 12 months, 24 months

    A concise, generic measure of self-reported health which is accompanied by weights reflecting the relative importance to people of different types of health problems

  10. Beck Depression Inventory (BDI)

    Time frame: Change measures: 0 months, 12 months, 24 months

    A short, self-administered questionnaire to quantify psychological and physical symptoms of depression. It includes 21 items, and participants are asked to rate each item using a 4-point Likert scale. The BDI is one of the most frequently used questionnaires for the assessment of depression in clinical practice, including in older adults.

  11. Hearing in real-life environment - HERE

    Time frame: Change measures: 0 months, 12 months, 24 months

    The HERE questionnaire is self-reporting hearing questionnaire validated in Finnish language (28). It includes 15 items with a numeric rating scale from 0 to 10 for each item and allows the assessment of hearing with and without hearing aids.

Other outcomes

  1. EEG-derived cortical auditory evoked potentials (CAEPs)

    Time frame: Change measures: 0 months, 12 months, 24 months

    The possible cortical changes related to the use of HA will be measured through EEG-derived cortical auditory evoked potentials (CAEPs) assessed while administering the DIN test.

  2. Structural MRI

    Time frame: Change measures: 0 months, 12 months, 24 months

    sMRI will provide measures of neurodegeneration (e.g., cortical thickness, brain volumes) and cerebrovascular pathology (e.g., white matter lesions, clinically "silent" infarcts). The scans will include T1, T2, FLAIR, and diffusion weighted sequences (~45 min).

  3. Functional MRI

    Time frame: Change measures: 0 months, 12 months, 24 months

    Task-based fMRI scans (~20 min) will be conducted on at least of 30 participants from both groups (60 altogether) closely mimicking the EEG-paradigm (section 3.3.1). To minimize the possible masking effect of scanner noise, the sounds will be presented during silent periods between scans.

  4. Ultra-short echo time MRI / Zero echo time MRI

    Time frame: Change measures: 0 months, 12 months, 24 months

    Task-based ultra-short- and zero echo time MRIs (UTE, ZTE) (~20 min) will also be conducted on the same group of participants having the fMRI described previously. The tasks will closely mimic the EEG-paradigm (section 3.3.1). Short echo time sequences are less sensitive to susceptibility and motion artifacts and the sequences are silent.

  5. Measures related to active lifestyle

    Time frame: Change measures: 0 months, 12 months, 24 months

    Participants will receive a self-administered questionnaire covering several lifestyle domains potentially affected by HI and relevant for dementia risk, e.g. physical, cognitive and social activities. An active lifestyle index will be calculated as a composite score based on these domains.

  6. Digital cognitive test battery

    Time frame: Change measures: 0 months, 12 months, 24 months

    The cognitive test battery includes tests covering different cognitive domains, and available within the public domain. It was adapted and already tested for persons with HI by Prof. Vincent Lin at Sunny Brook University Hospital, Canada, by converting all original verbal instructions into a visual PowerPoint presentation shown on a computer screen. In the HAHA trial, the cognitive test battery will be self-administered by the participant on the DigiKuulo screen at the study site.

  7. 1: Vision-related outcomes

    Time frame: Change measures: 0 months, 24 months

    Best-corrected visual acuity

  8. 2: Vision-related outcomes

    Time frame: Change measures: 0 months, 24 months

    Slit-lamp examination

  9. 3: Vision-related outcomes

    Time frame: Change measures: 0 months, 24 months

    Retinal imaging

  10. 4: Vision-related outcomes

    Time frame: Change measures: 0 months, 24 months

    Eye geometrics and biometric values

  11. Blood samples

    Time frame: Change measures: 0 months, 24 months

    Frozen and stored for future assessment of HI or dementia- related markers (e.g. genetic, amyloid, tau, neurodegeneration)

  12. Intervention-related acitivities, intervention group

    Time frame: Change measures: 0 months, 3 months, 6 months, 12 months

    Amplification of HAs

  13. Intervention-related acitivities, standard group

    Time frame: Change measures: 0 months

    Amplification of HAs

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Eastern Finland

Registry information

Official study title

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.

Acronym: HAHA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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