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

NCT03532152 | Completed

• 1 other identifier: PurePurr-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

VR; moderate stress

Outcome Measures

Primary Outcomes (1)

• Power in high frequency range (HF) [ms2]

  Change from Power in high frequency range (HF) \[ms2\] at 5 minutes before and after VR technology using

  The outcome measure will be assessed between two visits with minimum interval 24 up to seven days

Secondary Outcomes (7)

• The square root of the mean of the sum of the squares of differences between adjacent NN intervals (rMSSD), [ms]

  The outcome measure will be assessed between two visits with minimum interval 24 up to seven days

• Standard deviation of all NN intervals (SDNN), [ms]

  The outcome measure will be assessed between two visits with minimum interval 24 up to seven days

• Ratio Power in low frequency range [ms2]/ Power in high frequency range [ms2] (Ratio LF [ms2]/HF [ms2])

  The outcome measure will be assessed between two visits with minimum interval 24 up to seven days

• Total power (TP), [ms2]

  The outcome measure will be assessed between two visits with minimum interval 24 up to seven days

• Heart Rate (HR) variable.

  The outcome measure will be assessed between two visits with minimum interval 24 up to seven days

Study Arms (2)

Pure Purr VR technology

ACTIVE COMPARATOR

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

Sham VR technology

SHAM COMPARATOR

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

Interventions

Pure Purr VR technology DEVICE

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.

Pure Purr VR technology

Sham VR technology DEVICE

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.

Sham VR technology

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pure Purr LLC: lead
• Pharmaxi LLC: collaborator

Study Sites (1)

Doctor Sam Medical Network

Kyiv, Kyiv Oblast, Ukraine

Location

Study Officials

• Sam Aganov, Ph.D.

  Dr. Sam LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 22, 2018
• Study Start: February 26, 2018
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)