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

NCT03532152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2019-04-16

No results posted yet for this study

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

Interventions

DEVICE

Pure Purr VR technology

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.

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.

Sponsors & Collaborators

  • Pharmaxi LLC

    collaborator INDUSTRY

  • Pure Purr LLC

    lead OTHER

Principal Investigators

  • Sam Aganov, Ph.D. · Dr. Sam LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2018-11-14
Completion
2018-11-14

Countries

  • Ukraine

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532152 on ClinicalTrials.gov