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

January 24, 2026 updated by: Eumorphia Remboutsika, University of Athens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Plasma medicine is a novel, exciting, young interdisciplinary scientific field, emerging from the interaction of physicists, biologists, and medical doctors. Plasma is the fourth matter, often defined as an ionized gas produced by the disintegration of polyatomic gas molecules or the removal of electrons from monatomic gas shells, with the following strict criteria: plasma must be a) macromolecularly neutral (quasi-neutrality); b) Debye shielding; c) frequency. As a result, plasma can be defined as "a quasi-neutral gas containing many interacting free electrons and ionized atoms and molecules, which have collective behavior caused by long-range coulomb forces", and their motion gives rise to electric fields and generates currents and magnetic fields. Plasma is classified into high-temperature, thermal, and non-thermal categories. In high temperature, all particles (both electrons and heavy particles) have the same temperature, and are thus in thermal equilibrium. Non-thermal (non-equilibrium) plasma engulfs particles that are not in thermal equilibrium. This plasma is termed "cold plasma". Cold plasma discharge can be achieved at both low pressure and atmospheric pressure. Low pressure cold plasma was first applied for surface decontamination in a more effective manner than conventional sterilization in the 1960s; by contrast, Cold Atmospheric Plasma (CAP) was applied in 1990s.

CAP is ideal for use in modern medicine because : a) it can be generated easily from a portable device with easier direct access to affected cells and tissues, b) all animal and human tissues contain water and its presence is undesirable in low pressure conditions, c) its ability to reduce microbial load makes it a good option to combat increasing antibiotic resistance, and d) CAP-generating devices have relatively low manufacturing costs. As a result, accessible, efficient, and inexpensive CAP devices can reduce the financial burden imposed on the health budget by conventional treatments.

All plasma devices used in clinical practice are intended to prevent harm to healthy cells. They undergo multistep testing and are associated with no significant side effects. Nevertheless, the proper CAP dosage must be continuously monitored, adjusted for each treatment, with an important parameter to be the distance between the plasma jet source and human skin. Hypothetically speaking, it could not be excluded that CAP does not have some minimal negative effects at the molecular level; these are still subject to ongoing analysis, but results so far suggest that hypothetically unproven adverse effects are outweighed by the enormous benefits of CAP.

Current analyses of CAP effects have concentrated mostly on cells in culture and animal models. Although these efforts are more accessible and easier to conduct, wider testing of CAP effects in disease and regenerative medicine studies in human patients could only be beneficial. Nowadays, CAP is mostly employed in aesthetic procedures; however, its use in more serious medical conditions, such as acute and chronic wounds, oral bacterial infections, and potentially in tumour therapy, is subject to ongoing research. The use of CAP in routine clinical practice in medicine could advance the therapeutic process into a less invasive and distressing process for patients, while also significantly reducing the financial burden of existing treatments in Europe and worldwide.

Aim of the Study: This cross-over single-blinded study evaluates the effect of a novel CAP jet-producing device, the Human Regenerator Power Jet (CE 2022), 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 [HR-QoL].

Participants: 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 were not aware whether they were subjected to CAP or AIR from the device. The HR-QoL study was conducted among adult residents of Greece, according to the World Medical Association Declaration of Helsinki (2013). In the HR-QoL study, "adults" are defined as individuals no younger than 18 years old. The eligible list of participants has been evaluated by the Endocrine Unit of the University of Athens (NKUA).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • The Endocrine Unit of the University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria Clinical and laboratory diagnosis of chronic stress/chronic pain/chronic fatigue/Long Covid Criteria:

Exclusion Criteria include:

  1. Pregnancy or Breast-feeding period
  2. Participation on another Stress related study
  3. Patients with implanted devices
  4. Patients with major psychiatric disorders
  5. Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CAP to AIR
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
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
Device: Atmospheric Air
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
Sham Comparator: AIR to CAP
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
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
Device: Atmospheric Air
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EURO-QOL Quality of Life Health Assessment (License no. 62101)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Collaborators

THE ENDOCRINE UNIT OF THE UNIVERSITY OF ATHENS

Investigators

  • Principal Investigator: Eumorphia Remboutsika, PhD, University Research Institute for the Study of Genetic & Malignant Disorders in Childhood
  • Study Director: George P Chrousos, MD, PhD, University Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Actual)

July 22, 2025

Study Completion (Actual)

July 22, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPURI9023
  • License 62101 (Other Identifier: EuroQoL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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