StressNCT03532152
Study of the Effect of the VR Technology on Recovery of the Autonomic Nervous System in Volunteers Affected by Stress
A study testing Pure Purr VR technology in people with Stress, run by Pure Purr LLC at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Pure Purr VR technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUkraine
- Study dates
- 26 Feb 2018to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Stress
- Being tested
- Pure Purr VR technology, Sham VR technology
- Keywords
- VR, moderate stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure Purr VR technologyDevice
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 VR technologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham VR technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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]
Change from rMSSD variable at 5 minutes before and after VR technology using
Measured: 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]
Change from SDNN variable at 5 minutes before and after VR technology using
Measured: 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])
Change from Ratio LF [ms2]/HF [ms2] at 5 minutes before and after VR technology using
Measured: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Total power (TP), [ms2]
Change from Total power (TP) variable at 5 minutes before and after VR technology using
Measured: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Heart Rate (HR) variable.
Change from Heart Rate (HR) variable at 5 minutes before and after VR technology using
Measured: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
BP (both systolic and diastolic blood pressure) variable.
Change from systolic and diastolic blood pressure at 5 minutes before and after VR technology using
Measured: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Spielberger state-trait anxiety inventory (STAI) variable.
Change from STAI variable at 5 minutes before and after VR technology using. STAI-Examination of the level of situational anxiety.
Statement for еxamination:
- Calm down
- Safe
- Tense
- Annoyed
- Comfortable
- Upset
- Concerned with future misfortunes
- Relaxed
- Anguished
- At ease
- Self-confidence
- Nervous
- Restless
- Downhearted
- Rested
- Satisfied
- Concerned
- Stunned
- Happy
- I fell good
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:
- up to 30 points - low,
- 31 - 44 points - moderate;
- 45 and more - high.
Measured: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start26 Feb 2018
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pure Purr LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmaxi LLC
- Responsible party
- Sponsor
- Investigators
- Sam Aganov, Ph.D., Principal investigator, Dr. Sam LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532152
- Sponsor's protocol ID
- PurePurr-001
- Status last verified
- Apr 2019
- First submitted
- 2 May 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03532152
- Acronym / sponsor ID
- PurePurr-001
- Conditions
- Stress
- Keywords
- VR, moderate stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Pure Purr LLCUniversity, hospital or other
- Collaborators
- Pharmaxi LLC
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pure Purr VR technology | Active comparator | Device: Pure Purr VR technologyThe 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. |
| Sham VR technology | Sham comparator | Device: Sham VR technologyThe 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure Purr VR technologyThe 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 | Pure Purr VR technology |
| Sham VR technologyThe 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. | Device | Sham VR technology |
Primary outcome
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
Change from Power in high frequency range (HF) [ms2] at 5 minutes before and after VR technology using
7 secondary outcomes
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
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
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
Total power (TP), [ms2]
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
Heart Rate (HR) variable.
Time frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Aganov, Ph.D. principal investigator
Dr. Sam LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure Purr VR technology in people with Stress, run by Pure Purr LLC at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.