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Validation of the Philips EmoGraphy technology to measure sympathetic nervous system activity in an ambulatory setting

Validation of the Philips EmoGraphy technology to measure sympathetic nervous system activity in an ambulatory setting - Autonomic nervous system activity and emotions in daily life.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44295
Enrollment
110
Registered
2017-12-13
Start date
2017-12-15
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotionele spanningen en stress mood stress

Interventions

None listed

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)