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. 2021 Mar 23;14:568051. doi: 10.3389/fnhum.2020.568051

Table 3.

Minimum reporting standards.

Acute/short-term stimulation Long-term stimulation
Device level
– Manufacturer/name/version/edition (if applicable)
– Regulatory aspects (CE certification, FDA compliance etc.)
Design level
– General study design (e.g., randomized controlled)
– Between- vs. within-subject design (if applicable)
– Blinding of subjects, assessors, and statisticians
– Intended and actual session duration (min)
– Pre-stimulation period (i.e., time before task/segment of interest)
– Time of day (circadian influence)
– Manipulation check (in sham-controlled designs)
– Type of sham control (if applicable)
– General study design (e.g., randomized controlled)
– Between- vs. within-subject design (if applicable)
– Blinding of subjects, assessors, and statisticians
– Intended and actual daily dose/total duration of intervention
– Time of day of stimulation (i.e., free vs. instructed)
– Protocol compliance monitoring and completer definition
Stimulation level (for active and sham stimulation, if applicable)
– Stimulation site (specify anatomic location and steps in preparation) (e.g., using an alcohol wipe)
– Electrode composition and set-up
– Current intensity (mA)
– Pulse width (μs)
– Frequency (Hz)
– Duty cycle (s)
– Parameter descriptions: Constant current or voltage, current or voltage intensity (mA or V), pulse width, frequency, duty cycle (ON/OFF time)
– Waveform descriptions: uni- or bi-directional, anode/cathode placement
– Pulse shape and burst/non-burst stimulation
– Voltage (mV) in case of voltage-controlled stimulation
Subject level
– Inclusion/exclusion criteria
– Mean age and age range of sample
– Sex distribution/ethnicity
– Assessment of confounding variables
– Prior knowledge of vagal innervation of the ear by the participant
Adverse events
– Detailed reporting on methods to assess adverse events
– Transparent reporting on any (serious) adverse events