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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03532152
• Date of registration: 02/05/2018
• Prospective Registration: No
• Primary sponsor: Pure Purr LLC
• Public title: Study of the Effect of the VR Technology on Recovery of the Autonomic Nervous System in Volunteers Affected by Stress
• Scientific 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
• Date of first enrolment: February 26, 2018
• Target sample size: 94
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03532152
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Ukraine

Contacts

• Name: Sam Aganov, Ph.D.
• Affiliation: Dr. Sam LLC

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stress

Intervention(s)

Device: Pure Purr VR technology

Device: Sham VR technology

Primary Outcome(s)

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]

Secondary Outcome(s)

Heart Rate (HR) variable. [Time Frame: The outcome measure will be assessed between two visits with minimum interval 24 up to seven days]

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]

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]

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]

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]

Total power (TP), [ms2] [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]

Secondary ID(s)

PurePurr-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pharmaxi LLC