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| Name | Class |
|---|---|
| University of Eastern Finland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Speech, Spatial and Quality questionnaires - SSQ | 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. | Change measures: 0 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| EEG-derived cortical auditory evoked potentials (CAEPs) | 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. | Change measures: 0 months, 12 months, 24 months |
| Structural MRI |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aarno Dietz, prof. | Kuopio University Hospital and University of Eastern Finland | Principal Investigator |
| Alina Solomon, prof. | University of Eastern Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | 70210 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33714390 | Background | GBD 2019 Hearing Loss Collaborators. Hearing loss prevalence and years lived with disability, 1990-2019: findings from the Global Burden of Disease Study 2019. Lancet. 2021 Mar 13;397(10278):996-1009. doi: 10.1016/S0140-6736(21)00516-X. | |
| 32738937 | Background | Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available. |
| Label | URL |
|---|---|
| WORLD REPORT ON HEARING | View source |
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The HAHA Steering Committee and Management Group are open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. Committee will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing HAHA analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the HAHA Management Group. Access is subject to the HAHA legal framework. An access agreement will be prepared and signed by both parties.
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.
As described above in the Plan Description.
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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.
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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.
|
| 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. |
|
| Hearing aid usage (self-report and HAs log data) | 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. | Change measures: 0 months, 12 months, 24 months |
| Listening effort questionnaire | 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. | Change measures: 0 months, 12 months, 24 months |
| Response time (DIN test) | Response time for the answers given by the participant will be calculated and recorded automatically | Change measures: 0 months, 12 months, 24 months |
| Tinnitus Handicap Inventory (THI) | 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'. | Change measures: 0 months, 12 months, 24 months |
| CERAD-nb (global and domain scores) | 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). | Change measures: 0 months, 12 months, 24 months |
| Clinical Dementia Rating Sum of Boxes (CDR-SoB) | 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). | Change measures: 0 months, 12 months, 24 months |
| 15D questionnaire | 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. | Change measures: 0 months, 12 months, 24 months |
| EQ5-D-5L questionnaire | 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 | Change measures: 0 months, 12 months, 24 months |
| Beck Depression Inventory (BDI) | 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. | Change measures: 0 months, 12 months, 24 months |
| Hearing in real-life environment - HERE | 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. | 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). |
| Change measures: 0 months, 12 months, 24 months |
| Functional MRI | 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. | Change measures: 0 months, 12 months, 24 months |
| Ultra-short echo time MRI / Zero echo time MRI | 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. | Change measures: 0 months, 12 months, 24 months |
| Measures related to active lifestyle | 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. | Change measures: 0 months, 12 months, 24 months |
| Digital cognitive test battery | 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. | Change measures: 0 months, 12 months, 24 months |
| 1: Vision-related outcomes | Best-corrected visual acuity | Change measures: 0 months, 24 months |
| 2: Vision-related outcomes | Slit-lamp examination | Change measures: 0 months, 24 months |
| 3: Vision-related outcomes | Retinal imaging | Change measures: 0 months, 24 months |
| 4: Vision-related outcomes | Eye geometrics and biometric values | Change measures: 0 months, 24 months |
| Blood samples | Frozen and stored for future assessment of HI or dementia- related markers (e.g. genetic, amyloid, tau, neurodegeneration) | Change measures: 0 months, 24 months |
| Intervention-related acitivities, intervention group | Amplification of HAs | Change measures: 0 months, 3 months, 6 months, 12 months |
| Intervention-related acitivities, standard group | Amplification of HAs | Change measures: 0 months |
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| 34972121 | Background | Sanders ME, Kant E, Smit AL, Stegeman I. The effect of hearing aids on cognitive function: A systematic review. PLoS One. 2021 Dec 31;16(12):e0261207. doi: 10.1371/journal.pone.0261207. eCollection 2021. |
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| 26808979 | Background | Hong T, Mitchell P, Burlutsky G, Liew G, Wang JJ. Visual Impairment, Hearing Loss and Cognitive Function in an Older Population: Longitudinal Findings from the Blue Mountains Eye Study. PLoS One. 2016 Jan 25;11(1):e0147646. doi: 10.1371/journal.pone.0147646. eCollection 2016. |
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| 17927921 | Background | Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007 Oct;11(42):1-294. doi: 10.3310/hta11420. |
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| 29562543 | Background | Panza F, Lozupone M, Solfrizzi V, Sardone R, Dibello V, Di Lena L, D'Urso F, Stallone R, Petruzzi M, Giannelli G, Quaranta N, Bellomo A, Greco A, Daniele A, Seripa D, Logroscino G. Different Cognitive Frailty Models and Health- and Cognitive-related Outcomes in Older Age: From Epidemiology to Prevention. J Alzheimers Dis. 2018;62(3):993-1012. doi: 10.3233/JAD-170963. |
| 36469314 | Background | Yeo BSY, Song HJJMD, Toh EMS, Ng LS, Ho CSH, Ho R, Merchant RA, Tan BKJ, Loh WS. Association of Hearing Aids and Cochlear Implants With Cognitive Decline and Dementia: A Systematic Review and Meta-analysis. JAMA Neurol. 2023 Feb 1;80(2):134-141. doi: 10.1001/jamaneurol.2022.4427. |
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| Development of the "Hearing In Real-Life Environments" Questionnaire | View source |
| Methods for Analysing and Reporting EQ-5D Data \[Internet\]. Cham (CH): Springer; 2020. Chapter 1, An Introduction to EQ-5D Instruments and Their Applications | View source |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D060825 | Cognitive Dysfunction |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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