Cognitive Decline, Sensorineural Hearing Loss
Conditions
Keywords
Hearing Impairment, Hearing Rehabilitation, Hearing Loss, Cognition, Data-driven rehabilitation
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.
Detailed 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.
Interventions
OTHERIndividualised data-driven hearing rehabilitation
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.
OTHERStandard care hearing rehabilitation
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.
Sponsors
Kuopio University Hospital
University of Eastern Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Finnish Matrix Sentence Test (FMST) | 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). |
| Digits in Noise test (DIN) | 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
| Measure | Time frame | Description |
|---|---|---|
| Speech, Spatial and Quality questionnaires - SSQ | 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. |
| Hearing aid usage (self-report and HAs log data) | 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. |
| Listening effort questionnaire | 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. |
| Response time (DIN test) | Change measures: 0 months, 12 months, 24 months | Response time for the answers given by the participant will be calculated and recorded automatically |
| Tinnitus Handicap Inventory (THI) | 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'. |
| CERAD-nb (global and domain scores) | 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). |
| Clinical Dementia Rating Sum of Boxes (CDR-SoB) | 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). |
| 15D questionnaire | 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. |
| EQ5-D-5L questionnaire | 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 |
| Beck Depression Inventory (BDI) | 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. |
| Hearing in real-life environment - HERE | 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. |
Countries
Finland
Contacts
PRINCIPAL_INVESTIGATORAarno Dietz, prof.
Kuopio University Hospital and University of Eastern Finland
PRINCIPAL_INVESTIGATORAlina Solomon, prof.
University of Eastern Finland
Outcome results
None listed