Study of the Effect of the VR Technology on Recovery of the Autonomic Nervous System in Volunteers Affected by Strees.

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stress	Device: Pure Purr VR technology; Device: Sham VR technology	Not Applicable

Detailed Description:

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 the investigator's 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Investigator)
Primary Purpose:	Other
Official Title:	Clinical Study of the Effect of the Virtual Reality (VR) Technology on Recovery of the Indicators of the Autonomic Nervous System in Healthy Volunteers Affected by Moderate Strees.
Actual Study Start Date :	February 26, 2018
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Pure Purr VR technology; The arm will use the virtual reality headset reproduces a dynamic video content that is visually perceived with the help of the high-resolution screen. The total length of the audio-video sequence is 6 minutes 11 seconds, of which 1 minute 11 seconds is the Pure Purr promotional video, and the duration of the investigational audio-visual sequence itself is 5 minutes.	Device: Pure Purr VR technology; The Pure Purr technology consists of a virtual reality 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.
Sham Comparator: Sham VR technology; The arm will use the headset with 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. The total length of the audio-video sequence is 6 minutes 11 seconds, of which 1 minute 11 seconds is the Pure Purr promotional video, and the duration of the investigational audio-visual sequence itself is 5 minutes.	Device: Sham VR technology; 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.

Outcome Measures

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Primary Outcome Measures :

1. Change in HF-HRV [ Time Frame: The measurement must be on the first and second visits. ]
   Change Heart rate variability (HRV) after 5-minute exposure to the VR audio-visual sequence

Secondary Outcome Measures :

1. rMSSD variable [ Time Frame: The measurement must be on the first and second visits. ]
   Change Root Mean Square of the Successive Differences (rMSSD) after 5-minute exposure to the VR audio-visual sequence.
2. LF/HF variable [ Time Frame: The measurement must be on the first and second visits. ]
   Change LF/HF variable after 5-minute exposure to the VR audio-visual sequence
3. SDNN variable [ Time Frame: The measurement must be on the first and second visits. ]
   Change SDNN variable after 5-minute exposure to the VR audio-visual sequence
4. HRV spectrum total output variable [ Time Frame: The measurement must be on the first and second visits. ]
   Change Heart rate variable (HRV) spectrum total output variable after 5-minute exposure to the VR audio-visual sequence
5. HR variable [ Time Frame: The measurement must be on the first and second visits. ]
   Change Heart Rate (HR) variable after 5-minute exposure to the VR audio-visual sequence
6. BP variable [ Time Frame: The measurement must be on the first and second visits. ]
   Change BP (systolic and diastolic blood pressure) variable after 5-minute exposure to the VR audio-visual sequence
7. Spielberger state-trait anxiety inventory (STAI) variable [ Time Frame: The measurement must be on the first and second visits. ]
   Change Spielberger state-trait anxiety inventory (STAI) variable after 5-minute exposure to the VR audio-visual sequence. Scores range from 20 to 80, with higher scores correlating with greater anxiety. In this trial does not using any subscale for this scale.

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Females and males 20-60 years old;
2. Volunteers have no history of cardiovascular diseases;
3. Volunteers have no essential abnormalities on the ECG;
4. Normal or moderate level of situational anxiety based on the Spielberger State-Trait Anxiety Inventory (STAI);
5. Signed Informed Consent Form for participation in the study.

Exclusion Criteria:

1. Intolerance to the VR technology;
2. HR 110 bpm or below 50 bpm;
3. RR above 23 breaths per minute;
4. Abuse of alcohol, psychotropic substances and narcotic agents;
5. Smoking more than 100 cigarettes a week;
6. Administration of medicinal products for the treatment of cardiovascular and nervous system diseases 3 days prior to participation in the study;
7. Drinking tonics and energy drinks for at least 2 hours prior to participation in the study;
8. Severe or acute forms of respiratory, urogenital, gastrointestinal, haematological, metabolic, endocrine, or neurological diseases;
9. Mental disorders, which, in the opinion of the investigator, may distort the results of the study;
10. Participation in any clinical study over the last 3 months prior to enrolment to the study;
11. Parkinson's disease, Parkinson's symptoms, tremor, restless leg syndrome, and other motility disorders;
12. Pregnancy;
13. Any disease of the thyroid gland.

Contacts and Locations

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Contacts

Contact: Yevhen Vasylenko, MBA, MIB, MM	+38 (050) 330-7001	yevhenvasylenko@gmail.com
Contact: Sam Aganov, Ph.D.	+38 (044) 392 92 91	info@doctorsam.ua

Locations

Ukraine
Doctor Sam Medical Network	Recruiting
Kyiv, Kyiv Region, Ukraine
Contact: Sam Aganov, Ph.D. +38 (044) 392 92 91 info@doctorsam.ua

Sponsors and Collaborators

Pure Purr LLC

Investigators

Principal Investigator:	Sam Aganov, Ph.D.	Dr. Sam LLC

More Information

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Responsible Party:	Pure Purr LLC
ClinicalTrials.gov Identifier:	NCT03532152 History of Changes
Other Study ID Numbers:	PurePurr-001
First Posted:	May 22, 2018
Last Update Posted:	November 2, 2018
Last Verified:	June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Pure Purr LLC:

VR; moderate stress