Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Inter-beat interval (IBI) |
Inter-beat interval is the recorded physiological parameter and defined as the time interval between consecutive R wave peaks in milliseconds which will be obtained via photoplethysmography device and the relevant further analysis will be carried on in a software which was shown to be valid and reliable in a clinical research setting. |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of intervention time as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
Change in Standard deviation of Normal-to-Normal intervals (SDNN) |
The standard deviation of Normal-to-Normal IBI of normal sinus beats in milliseconds. |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
Change in pNN50 (The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage ) |
The percentage of adjacent Normal-to-Normal intervals that differ from each other by more than 50 ms as percentage (%). |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
Change in RMSSD |
The root mean square of successive differences between normal (sinus) heartbeats in milliseconds. |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
Change in Total power |
Total power is the sum of the energy in the Low Frequency and High Frequency bands' spectral power for short-term recordings in units of ms2. |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
Change in HF band power and LF band power |
Spectral analysis of High Frequency band (Absolute power of the high-frequency band (0.15-0.4 Hz)) reflects parasympathetic activity and Spectral analysis Low Frequency band Absolute power of the low-frequency band (0.04-0.15 Hz)reflects baroreflex activity.These parameters will be calculated both as absolute (ms2) and relative units. Relative power is estimated as the percentage of total Heart Rate Variability (HRV) power or in normal units (nu), which divides the absolute power for a specific frequency band by the summed absolute power of the LF and HF bands in normalised units (nu). |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
LF/HF Ratio |
may estimate the ratio between sympathetic nervous system (SNS) and parasympathetic nervous system (PNS) activity under controlled conditions in units of ms2. |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
Galvanic Skin Response |
Electrical conductance between two electrodes attached on 2 fingers of the individual in units of micro-Siemens (µS). |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
SD1 |
SD1 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation perpendicular the line of identity. It measures short-term Heart Rate Variability in milliseconds and correlates with baroreflex sensitivity (BRS), which is the change in IBI duration per unit change in BP, and HF (high frequency) power. |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
|
Primary |
SD2 |
SD2 is one of the non-linear HRV measure and defined as Poincaré plot standard deviation along the line of identity. It measures short- and long-term HRV in milliseconds and correlates with LF power and baroreflex sensitivity (BRS). |
Average of 5 minutes of measurement as a pre-intervention baseline value as time point zero. Average of 20 minutes (intervention) as time point one and average of 5 min epoch right after the intervention as time point two. |
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