The primary aim of this study is to develop ecologically valid listening tests with realistic social consequences of speech understanding difficulties in which physiological outcome measures are applied. Specifically, we aim to develop a speech…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters include the pupil dilation response and
cardiovascular response (pre-ejection period [PEP] and respiratory sinus
arrhythmia [RSA]) during listening to speech, as well as speech perception
performance. Furthermore, subjective rating scales (experienced effort,
estimated performance, and tendency to give up listening), the data of two
validated questionnaires (subjective hearing difficulties, need for recovery,
inclusion of other in self and group feeling) and the performance on a verbal
working memory test and a symptom-validity test are part of the study
parameters.
Secondary outcome
Blood pressure and hearing acuity.
Background summary
In today*s ageing European population, hearing impairment is an increasing
concern for public health and societal participation. The percentage of
hearing-impaired people will rise from around 16% of the adult EU population
now to around 40% in 2030. Hearing aid (HA) fitting is the most widely
prescribed solution for hearing impairment. However, only around 30%-40% of
adults with hearing impairment use HAs in daily life. One of the reasons for
this is that methods used to develop and evaluate HAs are still not based on
conditions in which HAs are actually used. Thus the potential of improved HA
technology to meet the needs of individual users in their daily lives is
acutely underexploited. The science in HEAR-ECO will help to facilitate the
paradigm shift which is needed to bridge the gap.
Study objective
The primary aim of this study is to develop ecologically valid listening tests
with realistic social consequences of speech understanding difficulties in
which physiological outcome measures are applied. Specifically, we aim to
develop a speech perception tests in which feedback is provided. We will
manipulate the task auditory demands by manipulating sentence complexity. The
outcome measure includes physiological measures of the pupil dilation response
and cardiovascular measures. These measures are associated with the sympathetic
and parasympathetic activity of the autonomous nervous system, and are
sensitive to listening effort. We hypothesize that increased auditory task
demands and social feedback will increase the listening effort as reflected by
the physiological measures.
Study design
Experimental study
Study burden and risks
Participating in this study does not involve any health risks. Participants
have to perform one test session (site visit to VUmc) of 1.5-2.5 hours,
respectively.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: aged between 18 and 80 years of age, native speakers
of Dutch, normal or corrected-to-normal eyesight. Listeners with hearing loss
should have average pure tone hearing thresholds (across 1000, 2000 and 4000
Hz) of at least 35 dB HL in both ears. We aim to include an equal number of
female and male participants in each of the studies in order to improve the
generalizability of the results.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: Listeners with normal hearing should have
age-normal hearing (ISO 7029, 2000). General exclusion criteria: having a
history of a neurological, psychiatric disease or using psychoactive drugs.
Additional exclusion criteria for Studies 2, 4 and 5 (related to the
cardiovascular measures collected in these studies): having a history of
cardiovascular diseases, anatomic abnormalities such as: aortic valve
regurgitation and defect of septum, aortic prosthesis, cardiac shunts, severe
aortic sclerosis, and intra-aortic pumps or having a pacemaker. Severe
hypertension (MAP > 130 mmHg), cardiac arrhythmia, tachycardia with a heart
rate higher than 200 bpm, aortic balloon or aortic balloon pump. These
abnormalities and dysfunctions may impede the reliable measurement of the ECG
and ICG.
The exclusion criteria for each of the studies except Study 2 also include
(eye-) diseases such as diabetes mellitus and cataract that may influence the
pupil dilation response. Additional exclusion criteria for Study 5 entail
psychological disorders that may affect social skills such as disorders on the
autistic spectrum and any disorders that affect social perception such as
social anxiety. Furthermore, participants that have experienced extreme nausea
when using virtual reality technology before this experiment will be excluded
as well. Finally, because of limited space in the virtual reality head-mounted
display participants cannot wear glasses. Participants who normally wear
glasses and cannot substitute with contact lenses have to be excluded.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL66213.029.18 |