The Effect of the Human Regenerator Jet Device on the Quality of Life of Adult Individuals [HR-QoL]

NCT07279272 | Completed

• 2 other identifiers: RPURI9023License 62101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-over single-blinded study aims to evaluate the effect of a novel cold atmospheric plasma jet-producing device, the Human Regenerator Power Jet device, for individuals who suffer from chronic stress, chronic pain, chronic fatigue, sleep disorders, and Post-COVID/Long-COVID Syndrome, all conditions that affect the QoL among adults in Greece and worldwide.

Conditions

Post-COVID / Long-COVID; Chronic Stress; Chronic Fatigue; Chronic Pain

Keywords

Cold Atmospheric Plasma; Human Regenerator Jet; Human Regenerator Power Jet; Human Regenerator Sports Jet; Human Regenerator Med Jet; Human Regenerator

Outcome Measures

Primary Outcomes (1)

• EURO-QOL Quality of Life Health Assessment (License no. 62101)

  The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in and it essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions (1-digit number/dimension), The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state and reflects to the overall health state of each individual (0-1 scale). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image' (0-100 scale).

  The time frame ranges from enrollment to completion in 10-11 weeks, with four time points: T1: Enrollment date; T2: 3 weeks; T3: 7 weeks; T4: 10 weeks-Completion date.

Study Arms (2)

CAP to AIR

ACTIVE COMPARATOR

Group A (20 adults) were subjected to Cold Atmospheric Plasma (10 sessions) generated by the Human Regenerator jet device (Active Device-CAP Effect), followed by a 1-month wash-out period, before being subjected to AIR (10 sessions) (Sham Device-Placebo Effect).

Device: Cold Atmospheric Plasma; Device: Atmospheric Air

AIR to CAP

SHAM COMPARATOR

Group B (20 adults) were subjected to AIR (10 sessions) generated by the Human Regenerator jet device (Sham Device-Placebo Effect) followed by a 1-month wash-out period, before being subjected to Cold Atmospheric Plasma conditions (10 sessions) (Active Device-Cap Effect)..

Device: Cold Atmospheric Plasma; Device: Atmospheric Air

Interventions

Cold Atmospheric Plasma DEVICE

The Human Regenerator Jet Device CAP Effect interventions include a 30 minute exposure of the subjects, every other day, with Cold Atmospheric Plasma, a total of 10 sessions

AIR to CAP; CAP to AIR

Atmospheric Air DEVICE

The Human Regenerator Jet Device AIR Effect interventions include a 30 minute exposure of the subjects, every other day, to Atmospheric Air, a total of 10 sessions

AIR to CAP; CAP to AIR

Eligibility Criteria

• Age: 18 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnancy or Breast-feeding period
• Participation on another Stress related study
• Patients with implanted devices
• Patients with major psychiatric disorders
• Refusal to participate in the study

Sponsors & Collaborators

• THE ENDOCRINE UNIT OF THE UNIVERSITY OF ATHENS: collaborator
• University of Athens: lead

Study Sites (1)

The Endocrine Unit of the University of Athens

Athens, Greece

Location

Related Links

• Human Regenerator Jet Device

MeSH Terms

Conditions

Chronic Pain; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Eumorphia Remboutsika, PhD

  University Research Institute for the Study of Genetic & Malignant Disorders in Childhood

  PRINCIPAL INVESTIGATOR

• George P Chrousos, MD, PhD

  University Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher B ( Associate Professor Level)

Model Details: HR-QoL single-blind crossover study evaluates the effects of a novel cold atmospheric plasma jet producing device, the Human Regenerator Power Jet device (HR) (System4 Technologies GmbH, Germany) for individuals who suffer from chronic stress, chronic pain, chronic fatigue syndrome, sleep disorders, and Post-COVID/Long-COVID Syndrome, all conditions that affect the QoL among adults worldwide. The HR-QoL study has solicited 40 participants randomized into two groups (A \& B). Group A (20 adults) was treated at the HR under CAP conditions (CAP Effect) (10 sessions), followed by a 1-month wash-out period, before treatment at the HR under AIR Conditions (Sham Device-Placebo Effect). Group B (20 adults) was treated at the HR under AIR conditions (Sham Device-Placebo Effect) followed by a 1-month wash-out period, before treatment at the HR under CAP Conditions (Cap Effect). The participants are not aware whether they are subjected to CAP or AIR from the device.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 12, 2025
• Study Start: July 9, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)