To assess the feasibility of an RCT assessing the effects of hearing aids on cognitive decline.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Assess the willingness of *naïve* individuals to be randomized in a study
concerning cognition
Secondary outcome
• Assess the feasibility of the test battery for cognitive tests, at baseline
and six months
• Assess the therapy compliance of hearing aid use for individuals willing to
be randomized in an RCT
Background summary
In an era of increased longevity, society is facing new health care issues.
Considering the wide range of degrees of cognitive impairment with implications
for people*s life, cognitive decline is considered one of the greatest global
challenges for health and social care in the 21st century. Hearing loss is
recognized as one of the risk factors for developing cognitive decline.
Several hypotheses about the reasons for the relation between hearing loss and
cognition have been developed over the past years. Core to these is the theory
that the diminished auditory input profoundly affects speech processing
capabilities and consequently, impairs social functioning. Therefore,
individuals with hearing loss exhibit accelerated brain atrophy compared with
normal hearing adults, especially within the right temporal lobe structures,
that are critical for many cognitive functions.
Age related hearing loss is responsible for about 90% of the hearing loss cases
in adults. While it is easy to treat hearing loss with hearing aids, only about
one third of the adults with hearing loss use hearing aids. It is unknown
whether hearing improvement for those affected with hearing impairment will
result in less deterioration of cognitive decline by ageing. Therefore we will
conduct a feasibility study of an RCT assessing the effects of hearing aids on
cognitive decline.
Study objective
To assess the feasibility of an RCT assessing the effects of hearing aids on
cognitive decline.
Study design
Feasibility study for a randomized controlled trial
Intervention
Conventional type hearing aid
Study burden and risks
The participants will be asked for their willingness to be randomized to
hearing aids or not. After randomization participants receive a hearing aid in
the intervention and no treatment in the control group. At baseline and after 6
months of hearing aid use they will be asked to perform a cognitive test
battery to assess the feasibility of the tests and to assess therapy compliance
whereafter the study stops. The burden for the participant is low and there are
no risks associated with participation.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- 65 years of age or older at the time of consent
- >35-<50 dB PTA hearing loss (0.5-4 kHz) uni- or bilateral, as assessed in a
recent (less than 6 months old) hearing examination
- Not using a hearing aid at time of assessment
- No foreseen surgical interventions to restore hearing planned during the time
of the study follow-up.
Exclusion criteria
Participants will be excluded if they have severe cognitive impairment before
the start of the study or if they don*t speak the Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN84550071 |
| CCMO | NL80594.041.22 |