Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Healthy heaAring for Healthy Ageing Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing
Sponsor:
Kuopio University Hospital
Organization:
Kuopio University Hospital
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAHA
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 Our 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 11 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
Participants will be randomized 11 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 clinicaltrialsgov 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
We 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 will receive a phone call check in 2 months after the primary fitting and in addition they 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 monitoringre-fitting may be offered based on the participants feedback and hearing rehabilitators 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 included to investigate potential mechanisms underlying associations between HI hearing rehabilitation vision and cognition The overall duration of the this trial is 2 years
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 clinicaltrialsgov 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
We 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 will receive a phone call check in 2 months after the primary fitting and in addition they 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 monitoringre-fitting may be offered based on the participants feedback and hearing rehabilitators 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 included to investigate potential mechanisms underlying associations between HI hearing rehabilitation vision and cognition The overall duration of the this trial is 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None