The primary objective of this study is to determine the effect of intervention with a CI in post lingual adult patients with progressive severe hearing loss and thus residual hearing, compared to standard care with hearing aids, on societal related…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Participation is the primary outcome of the study and is measured by using the
Impact on Participation and Autonomy (IPA) questionnaire. The primary
parameters are obtained by the domains family role; social life and
relationships; and work and education.
Secondary outcome
Autonomy measured by IPA; domains: Autonomy outdoors, autonomy indoors.
Communication profile Measured by the Amsterdam Questionnaire for Hearing
Impairment and labour. The used domains are: Maladaptive behaviour, verbal
strategies, non-verbal strategies, self-acceptance, acceptance of loss, stress
and withdrawal.
Work Measured by using the Amsterdam Questionnaire for Hearing Impairment and
labour. The used domains are: Need for Recovery, participation, and relation to
co-workers.
Productivity loss measured by the Productivity Costs Questionnaire.
Quality of life questionnaires (the generic HUI-3 and the disease specific
NICQ) will be used in this study and are already part of standard clinical
practice.
Capabilities are measured by using the ICECAP-A questionnaire and by conducting
semi-structured interviews.
Cognition is measured by using the RBANS-H cognition test.
Listening effort is measured by pupillometry.
Background summary
Cochlear implantation (CI) has been successful in terms of rehabilitation of
severe to profound hearing loss. CI in adults with severe to profound hearing
loss resulted in significant gains in quality of life and psychosocial
wellbeing. In addition, cost-effectiveness of unilateral CI in adults with
severe to profound hearing loss has been demonstrated in various publications.
Most adults with moderate to severe hearing loss, show a decline in speech
recognition with progression of their disability, even when fitted with hearing
aids. Their disability might progress to a state in which societal
participation becomes difficult: the disability might influence social
participation, autonomy, work/occupational status and quality of life. In
recent years, due to improved outcome following CI technology, audiologic and
functional inclusion criteria for CI have broadened. As a result, more people
have become eligible for CI. Moreover, the number of patients who might benefit
from a CI is expected to increase further. Besides the expanded indication
there is an increase in awareness about CI effectiveness among the eligible
population. Also, due to the aging population more elderly will become eligible
for CI. This has resulted in increased waiting lists of almost two years in
some centers in the Netherlands. In this waiting period the patient*s condition
might be worsening.
It is hypothesized that after 1 year of CI use by patients with severe hearing
loss, there is an improvement on societal related outcomes compared to the
control group with conventional hearing aids. In addition, there is little to
no evidence about the potential societal benefits from early implantation. In
this study patients will receive early implantation in the intervention group
and the control group before they progress to profound hearing loss or deafness.
A long-term observational study is of importance to determine
cost-effectiveness, in which participants function as their own controls in a
within subject analysis. It is important for its scientific content but also
for its implications for healthcare policy. A similar study has not been
conducted yet.
Study objective
The primary objective of this study is to determine the effect of intervention
with a CI in post lingual adult patients with progressive severe hearing loss
and thus residual hearing, compared to standard care with hearing aids, on
societal related outcomes (participation; communication profile; autonomy;
cognition; listening effort; work; productivity loss; quality of life and
capability.)
The secondary objective is to determine the long term effects of CI in post
lingual adults with severe hearing loss on the same societal related outcomes
in an observational manner.
Study design
Randomized controlled trial followed by a prospective observational study.
Intervention
The primary intervention of this study is a CI at severe hearing loss compared
to best fitted hearing aids. To achieve this comparison participants will be
randomly divided into two groups. Participants in the intervention group will
receive a CI with an accelerated trajectory. Participants in the control group
will receive a CI according to the current standard trajectory.
By making this division we create a time period in which the intervention group
has a CI and the control group still uses hearing aids. Till this point in time
the comparison for answering our primary research question is possible.
Study burden and risks
In our view there is a relatively small additional burden by participating in
this study in relation to the standard CI procedure. In addition, we do not
foresee any health risks associated with study participation.
In this study we try to schedule study measurement appointments on moments when
the patient already visits the hospital for regular care.
Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are closely related to the clinical eligibiltiy criteria
maintained at the medical center.
In addition:
1.) Age between 18-65 years, the working population.
2.) Participants have severe post *lingual sensorineural hearing loss (as
defined by WHO criteria of 61-81 dB loss).
3.) Eligible for CI based on clinical criteria and on the following audiometric
data:
- best aided phoneme score * 70% at 65/70dB HL
- Communication need
4.) Sufficient understanding of the Dutch Language.
Exclusion criteria
The following exclusion criteria are maintained for the study.
1.) Patient has an underlying syndrome.
2.) Pre-lingual Hearing impaired individuals.
3.) Sudden hearing loss.
4.) Children 0 * 18 years old.
5.) Elderly 65+ years old.
6.) Profound hearing loss
7.) Any condition that may hamper a complete insertion of the electrode array
or a normal rehabilitation with the cochlear implant (severe otosclerosis or
neurologic deficits)
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 |
|---|---|
| CCMO | NL70869.091.19 |