Our main objective is to assess the effects of hearing impairment on the subjective and physiological stress responses experienced during acoustically and socially challenging real-life settings and relate these to features acquired during…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters of this study include:
1) the pupil response parameters as collected in the laboratory test session:
the peak pupil dilation response, principal component analyses parameters and
growth curve analysis parameters
2) the physiological measures collected in the ambulatory part of Experiment 1
and 3 by the VU-AMS, including the indices of SNS activity: Pre-Ejection Period
(PEP), Skin Conductance Level (SCL), non-specific Skin Conductance Response
(nsSCRs), indices of PNS activity: Respiratory Sinus Arrhythmia (RSA), Root
Mean Square of Successive Differences (RMSSD), and Heart-Period (HP).
3) the answers to the EMA questions in Experiment 1 and 3 (17 to 23 Likert
scale ratings about affective state, ongoing (social)activity, and listening
conditions, see F.1 vragenlijst ambulante metingen), in combination with the
six acoustical features extracted by the microphone set-up: the binaural root
mean square [RMS] loudness level, 2) the zero-crossing rate of the signal and
its first derivative, 3) the smoothed power spectral density and 4) cross power
spectral densities, the 5) smoothed Mel Frequency Cepstral Coefficients and 6)
the signal envelope.
Secondary outcome
1) performance and six subjective Visual Analogue Scale (VAS) ratings collected
in the speech perception in noise test
2) performance, pupil response parameters, subjective ratings and VU-AMS data
collected during the Paced Visual Serial Addition Test (PVSAT) test (Experiment
1 and 3)
3) questionnaire data (subjective hearing difficulties, coping with hearing
loss, hearing and work, and need for recovery)
4) data automatically stored by the smartphone application, such as movement
data, temperature, illumination level, pedometer (Experiment 1 and 3).
Background summary
Hearing impairment is one of the most prevalent disabilities, affecting 466
million people worldwide (World Health Organization). Its prevalence will be
doubled in 2050 due to increasing life expectancy. Hearing loss is associated
with increased listening effort, subjective fatigue and stress in daily life,
which can lead to social isolation, cognitive problems, lost employment
opportunities and a poor quality of life. More insight into daily-life hearing
difficulties is urgently needed in order to develop diagnostic methods
sensitive to hearing-related stress in daily-life and to evaluate hearing
rehabilitation strategies.
Study objective
Our main objective is to assess the effects of hearing impairment on the
subjective and physiological stress responses experienced during acoustically
and socially challenging real-life settings and relate these to features
acquired during standardized audiological examination, including pupillometry.
To achieve this, our secondary objectives are
1) to examine the influence of hearing impairment on the relationship between
ANS activity and the pupil response to varying levels of auditory task demand
as measured during standardized laboratory testing. (Work-package [WP]1,
Experiment 2 and 3);
2) To examine the influence of hearing impairment on ambulatory measured
subjective stress and ANS activity during high auditory task demand in
daily-life settings. (WP2, Experiment 1 and 3); and
3) To find the (combination of) pupillometric features from standardized
laboratory testing that best predict the hearing-loss related changes in
subjective stress and ANS activity in daily life. (WP3, Experiment 1 and 3).
Study design
Experimental study. The experimental design of each Experiment includes a
2.5-hour laboratory session containing listening tests.
In Experiment 1 and 3, this followed by one or two 24-hour ambulatory
measurement sessions in the natural environment of the participant. During both
the laboratory protocol and the ambulatory measurement, participants will wear
the Vrije Universiteit Ambulatory Monitoring System (VU-AMS) to measure ANS
activity. In the laboratory, additional pupillometric measurement of listening
effort during a speech perception test will be used. During the ambulatory
recording in real-life hearing conditions, daily-life acoustic task demands
will be objectively assessed by online sound level and complexity feature
detection from an audio recording. In addition, smartphone based Ecological
Momentary Assessment (EMA) application of Ethica (s) will be used for
subjective assessment of listing effort and affective state, including the
experienced stress, for every +/- 120 minutes and for five measurement days.
Participants will also fill out several questionnaires. Also, the smartpohne
application will automatically store several passively acquired variables, like
pedometer info, movement of the phone, and light intensity levels.
The combination of laboratory-based and ambulatory data collected in Experiment
1 and 3 will allow us to assess which laboratory based parameters sensitively
predict high listening effort and physiological and subjective
stress-reactivity in daily life conditions.
Study burden and risks
All participants participate in a 2.5 hour laboratory test session. For
participants of Experiment 1 and 3, this is followed by one or two 24-hour
sessions of ambulatory recording of ANS activity and short two-hourly EMA
surveys during the awake time of five days. EMA is done through a smartphone
applet and takes 1 to 2 minutes to complete. A microphone continuously extracts
acoustical features of environment sounds, deleting the raw data so that no
identifying sound is recorded or can be reconstructed from the acoustical
features.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Aged 18-70 years (pilot studies) or aged 35 - 75 years (main study),
- native speaker of Dutch,
- normal or corrected-to-normal eyesight,
- age-normal hearing (ISO 7029, 2017) for normal hearing participants OR
- worse than age-normal hearing for non-congenital hearing impaired
participants OR
- having received a CI at least 1 year before, for CI users.
Exclusion criteria
- Currently suffering from a severe neurological or psychiatric disease, - Use
of psychoactive drugs - Use of drugs influencing ANS activity (e.g. β-blockers,
cholinergic agents), - Medication influencing skin or cardiac SNS activity
(hyperhidrosis related (e.g. glycopyrrolate ), cardiac related (e.g.
beta-blockers) or antidepressants (e.g. SNRIs)) - Metabolic disorders:
uncontrolled thyroid and/or adrenal disease - Alcohol abuse defined as: for men
> 21 units/week, for women > 14 units/week - Serious heart, pulmonary, hepatic
or renal diseases/impairment, malignant or haematological disease - Diagnosed
neuropathy - Having (eye-)diseases influencing the pupil response such as
diabetes mellitus and cataract.
Design
Recruitment
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL73714.029.20 |