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: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 84
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Contact Information
Primary
Laura Ihalainen, MD
laura.ihalainen@pshyvinvointialue.fi
+358447176801
Backup
Petteri Hyvärinen, DSc
petteri.hyvarinen@pshyvinvointialue.fi
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 200
Treatments
Active_comparator: 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.
Active_comparator: Standard care hearing rehabilitation
The participants in the control group will receive the standard care HA rehabilitation currently conducted at the KUH Hearing Center.
Related Therapeutic Areas
Sponsors
Collaborators: University of Eastern Finland
Leads: Kuopio University Hospital

This content was sourced from clinicaltrials.gov