Doctor Sam Medical Network
Kyiv, Kyiv Oblast, Ukraine
NCT Number: NCT03532152
The study assess the effect of the VR technology (Pure Purr technology) on the recovery of the autonomic nervous system in healthy volunteers affected by moderate stress. Study subject randomized into two groups: in Group 1 volunteers first be tested with the VR headset A, and during the next visit- headset B. Group 2 volunteers first be tested with the VR headset B, and during the next visit- headset A. Before, after and during VR session was conducted stress modulation and ECG recording.
The Pure Purr technology combines several audio and visual stimuli aimed at activation of the parasympathetic nervous system. Therefore, this study will investigate the effect of this technology on the recovery of autonomic nervous system performance after moderate stress.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Kyiv, Kyiv Oblast, Ukraine
Pure Purr technology is based on discoveries in neurophysiology, medicine, acoustics, and computer engineering, which are used to initiate the physiological process of recreation, i.e. allostasis. Literally this term means "achieving stability through change". This is an active mechanism playing a part in normalization of the tone of the autonomic nervous system and maintaining stability of the body internal environment. The condition in which all our functions are implemented fully and sparingly in response to the load, and the level of adaptation remains high for a long time. Pure Purr is a software and hardware complex for relaxation and recreation based on a virtual reality headset with a display with sufficient resolution, built-in processor, memory, and extended-range stereo speakers. Positive effect on the cognitive function of the brain and the system of neurohumoral regulation is achieved due to the synchronous actuation of a number of stimuli, such as: visual sequence enhanced by the effect of virtual reality, harmonious music with the binaural rhythm technology, and modified cat purrs. Currently, the use of each technology is a scientifically proven trigger for the activation of individual parts of the human nervous system. And combining them in one software complex enhances the overall effect.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Pure Purr technology consists of BoboVR X1 headset with pre-installed software. The virtual reality headset reproduces a dynamic video content that is visually perceived with the help of the high-resolution screen. Also, the headset is able to play audio and transmit it via the headphones.
The audio sequence has been modified by adding a binaural effect and has been synchronized with the tact of respiratory movements and the frequency of heart rate.
The sham technology includes an identical BoboVR X1 virtual reality headset with pre-installed software. The audio-visual sequence is similar to the one in the investigational version of the software. The key difference is that the audio sequence has not been modified with the binaural effect and has not been synchronized with the tact of respiratory movements and the frequency of heart rate.
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from Power in high frequency range (HF) [ms2] at 5 minutes before and after VR technology using
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from rMSSD variable at 5 minutes before and after VR technology using
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from SDNN variable at 5 minutes before and after VR technology using
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from Ratio LF [ms2]/HF [ms2] at 5 minutes before and after VR technology using
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from Total power (TP) variable at 5 minutes before and after VR technology using
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from Heart Rate (HR) variable at 5 minutes before and after VR technology using
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from systolic and diastolic blood pressure at 5 minutes before and after VR technology using
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Change from STAI variable at 5 minutes before and after VR technology using. STAI-Examination of the level of situational anxiety.
Statement for еxamination:
The range for each subscale from 1 to 4 point.
Processing of results:
Calculate the total score based on answers given by volunteers.
While interpreting the results, use the following levels of anxiety:
Pure Purr LLC
Other
Randomized, Prospective, Sham-controlled, Blinded, Cross-over Clinical Study of the Effect of the Virtual Reality (VR) Technology on Recovery of Indicators of the Autonomic Nervous System in Healthy Volunteers Affected by Moderate Stress
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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