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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Digits in Noise test (DIN)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Individualised data-driven hearing rehabilitation
Participants in the intervention group will receive data-driven, regularly controlled hearing aid rehabilitation that is not part of the standard care protocol.
干预措施: Individualised data-driven hearing rehabilitation (Other)
Standard care hearing rehabilitation
The participants in the control group will receive the standard care HA rehabilitation currently conducted at the KUH Hearing Center.
干预措施: Standard care hearing rehabilitation (Other)
结局指标
主要结局
Digits in Noise test (DIN)
时间窗: 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).
Finnish Matrix Sentence Test (FMST)
时间窗: 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).
次要结局
- 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)
- CERAD-nb (global and domain scores)(Change measures: 0 months, 12 months, 24 months)
- Clinical Dementia Rating Sum of Boxes (CDR-SoB)(Change measures: 0 months, 12 months, 24 months)
- 15D questionnaire(Change measures: 0 months, 12 months, 24 months)
- EQ5-D-5L questionnaire(Change measures: 0 months, 12 months, 24 months)
- Beck Depression Inventory (BDI)(Change measures: 0 months, 12 months, 24 months)
- Hearing in real-life environment - HERE(Change measures: 0 months, 12 months, 24 months)