The primary aim of this study is threefold. The first objective is to determine whether the SCL and the frequency of non-specific skin conductance response (nsSCRs) measured by the Philips GTEP Emography Bracelet are accurate measures of sympathetic…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric and behavioural symptoms NEC
Synonym
Health condition
Emotionele spanningen en stress
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
The main study parameters of this study consist of the SNS activity and
emotional tension measures. SNS activity is measured from the skin as SCL,
nsSCRs, and from cardiac activity as pre-ejection period (PEP) and ECG T-wave
amplitude (TWA). Emotional tension is quantified as scores on the visual
analogue FS (during the laboratory section) and the 3MQ (during the ambulatory
section).
Secondary outcome
Secondary study parameters/endpoints
Secondary study parameters consist of heart rate and heart rate variability
measures as obtained from PPG and the ECG. Using additional information on
respiratory behaviour, in the form of respiration rate (RR) and minute volume
(VE), respiratory sinus arrhythmia (RSA) will be computed as a measure of
parasympathetic nervous system (PNS) activity. This will allow a test of the
added value of PNS activity to predict emotional tension.
Other study parameters
Other parameters will be measured that (1) can be of influence on our
ambulatory SNS activity measures independent of emotional arousal, and (2) can
modify the relationship between SNS activity and emotional tension across
individuals.
The former consist of:
Physical activity and posture, measured by tri-axial accelerometry, energy
expenditure measured by indirect calorimetry (VO2), and ambient temperature
measured by a button worn on the outer clothing.
The latter consist of:
age, sex, educational attainment, medication and OC-use, (estimated) menstrual
phase (women), BMI, waist-hip ratio, fat percentage, physical fitness level
(estimated VO2 max), perceived physical and mental health, perceived stress
level during the past year, smoking behaviour, alcohol use and regular exercise
habits.
Background summary
In the past year Philips has been developing an ambulatory skin conductance
sensor that can accurately monitor an individual*s skin conductance levels
(SCL) over long periods of time. The intended application of this sensor is to
develop a personal coaching system based on the association between
fluctuations in an individual*s sympathetic nervous system (SNS) activity,
measured by SCL parameters, and reflecting emotional tension. The scientific
background on the association between SCL parameters and emotional tension in
an ambulatory setting is limited, because the majority of the traditional
emotional tension research is carried out in controlled laboratory situations.
It has been frequently shown that laboratory measurements of mood and distress
correlate only modestly with daily life mood and distress measurements.
Study objective
The primary aim of this study is threefold. The first objective is to determine
whether the SCL and the frequency of non-specific skin conductance response
(nsSCRs) measured by the Philips GTEP Emography Bracelet are accurate measures
of sympathetic nervous system activity. The second objective is to determine
whether fluctuation in SCL parameters can predict an individual*s subsequent
emotional tension in both a laboratory and ambulatory setting. The third
objective is to determine whether the use of additional signals, like posture,
physical activity, temperature and energy expenditure, can optimize the
predictive value of SCL parameters for emotional tension.
Secondary aim
The relationship between SNS activity and emotional tension is likely to be
variable across individuals. We will explore in ancillary analyses whether the
predictive validity of the Emography can be increased by taking into account
individual characteristics related to age, sex, educational attainment,
hormonal status, body composition, perceived health and stress, and lifestyle
behaviours.
Study design
The above defined objectives will be investigated using an experimental design
consisting of a two and a half hour laboratory protocol containing mental and
physical stressors followed by a ~22-hour ambulatory measurement in the natural
environment of the subject. During both the laboratory protocol and the
ambulatory measurement subjects will wear the Philips GTEP and the Vrije
Universiteit Ambulatory Monitoring System (VU-AMS) that combines impedance
cardiography and ECG recording using 7 surface electrodes. During part of the
laboratory protocol, subjects will wear the portable CosMed K4 O2/CO2 sensor to
measure their exact energy expenditure in parallel to wrist-based and hip-based
accelerometry. In the laboratory emotional tension will be manipulated through
exposure to various stressors and measured using the visual analogue Feeling
Scale (FS). In the field study natural fluctuations in emotional tension will
be measured every hour by the FS and the Maastricht Momentary Mood
Questionnaire (3MQ) administered through an Ipod/smartphone applet. During the
ambulatory measurement subjects will wear a button thermometer to measure
ambient temperature.
Study burden and risks
The risks of participation to this study are minimal as all measurements are
non-invasive. However, there is a non-trivial burden on the subjects as they
participate in a prolonged (2.5 hours) laboratory session followed by an
ambulatory recording session in which they wear a belt-based (Holter sized)
ambulatory recording device with a wrist-based smartwatch, and in which they
are prompted once per hour to briefly fill in a diary.
Benefits of the study are the active contribution to research that could
deliver evidence that a user-friendly strategy exists to validly measure
emotional state and sympathetic nervous system activity in real life settings.
This could be used to devise personalized preventive and intervention
strategies that are based on real-time assessment of mood and physiological
stress reactivity, i.e. they can be delivered *at the right time, at the right
place*.
Participants will also receive feedback on their 24 hour heart rate, skin
conductance level, and physical activity pattern, in an attractive visual form.
Van der Boechorststraat 1
Amsterdam 1081 BT
NL
Van der Boechorststraat 1
Amsterdam 1081 BT
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:
- Between the age of 18 and 48
- Currently employed or in schooling trajectory
- Living or working in the Amsterdam Metropolitan Area.
- Female subjects are premenopausal; use of hormonal contraceptives is acceptable
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Serious heart, pulmonary, hepatic or renal diseases/impairment, malignant or haematological disease
- Known diabetes or diagnosed neuropathy
- Irregularity of menstruation in premenopausal women
- 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
- Current psychiatric illness including eating disorders and depression
- Alcohol abuse defined as: for men > 21 units/week, for women > 14 units/week
- Pregnancy or breast feeding
- Inability to understand the study protocol (including language barriers)
- Inability to give informed consent
- Inability to participate in all phases of the protocol due to a disability (visual, reading, physical etc.)
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 | NL62442.029.17 |