- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03532152
Study of the Effect of the VR Technology on Recovery of the Autonomic Nervous System in Volunteers Affected by Stress
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kyiv Region
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Kyiv, Kyiv Region, Ukraine
- Doctor Sam Medical Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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. |
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. |
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Power in high frequency range (HF) [ms2]
Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Change from Power in high frequency range (HF) [ms2] at 5 minutes before and after VR technology using
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The square root of the mean of the sum of the squares of differences between adjacent NN intervals (rMSSD), [ms]
Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Change from rMSSD variable at 5 minutes before and after VR technology using
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Standard deviation of all NN intervals (SDNN), [ms]
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
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Ratio Power in low frequency range [ms2]/ Power in high frequency range [ms2] (Ratio LF [ms2]/HF [ms2])
Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Change from Ratio LF [ms2]/HF [ms2] at 5 minutes before and after VR technology using
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Total power (TP), [ms2]
Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Change from Total power (TP) variable at 5 minutes before and after VR technology using
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Heart Rate (HR) variable.
Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Change from Heart Rate (HR) variable at 5 minutes before and after VR technology using
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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BP (both systolic and diastolic blood pressure) variable.
Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Change from systolic and diastolic blood pressure at 5 minutes before and after VR technology using
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Spielberger state-trait anxiety inventory (STAI) variable.
Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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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:
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The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sam Aganov, Ph.D., Dr. Sam LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PurePurr-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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