Inflammatory Response After SurgeryPhase 1/2EOXNCT06968000
Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery and Sleep Quality in Postoperative Patients
A Phase 1/2 study testing EOX Anion-Enriched Hospital Room in people with Inflammatory Response After Surgery and Postoperative Recovery, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Airborne nanoparticle exposure is increasingly recognized as a significant contributor to oxidative stress, mitochondrial dysfunction, and low-grade systemic inflammation-factors that impair postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Response After Surgery, Postoperative Recovery
- What is being tested?
- EOX Anion-Enriched Hospital Room
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 1 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years, regardless of sex.
- Undergoing elective general surgery, preferably hepatobiliary procedures.
- Hospitalized for at least 4 days postoperatively in Unit 69 (HUFJD).
- Able to provide written informed consent.
- Considered to have medium or high risk of oxidative stress or mitochondrial dysfunction.
Who cannot join
- Surgery within the previous 6 months, either outpatient or inpatient.
- Diagnosed psychiatric or neurological disorders, including epilepsy.
- Active progressive cancer or chronic inflammatory disease.
- Cognitive impairment or inability to comply with study procedures.
- BMI ≥30 kg/m² (obesity class I or higher).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundacion Instituto de Investigacion Sanitaria Fjd
Madrid, Madrid, 28040
Héctor Guadalajara, MD, PhD, 0034 + 915504800 ext. 4331, h.guadalajara@quironsalud.es
Hector Guadalajara, MD, PhD
About this study
Official title: Pilot, Controlled, Double-blind Study to Evaluate the Effect of the Exposome Anionic Enrichment System (Biow) on Hospital Recovery Quality, Clinical Response, and Sleep Quality in Postoperative Patients
Airborne nanoparticle exposure is increasingly recognized as a significant contributor to oxidative stress, mitochondrial dysfunction, and low-grade systemic inflammation-factors that impair postoperative recovery. The World Health Organization and European initiatives such as the Human Exposome Project have highlighted the clinical importance of the exposome, defined as the totality of environmental exposures influencing health throughout life.
EOX is a CE-certified air regeneration system designed to modify the indoor exposome through a dual mechanism: advanced filtration and controlled emission of bioavailable anions using cold atmospheric plasma (CAP). Its multistage filter removes particulate matter, pathogens, and volatile organic compounds, while the anionic plasma phase modulates cellular oxidative balance and metabolic function.
Read more
Experimental and clinical data indicate that exposure to EOX improves mitochondrial efficiency, increases ATP production, and reduces oxidative protein damage. EOX has also been shown to influence molecular pathways involved in stress adaptation and repair, such as the HIF-1α-VEGF-EPO axis and protein synthesis signaling (e.g., mTOR-p70S6K). These mechanisms may collectively enhance tissue recovery, vascularization, and metabolic resilience in the postoperative setting.
The present study investigates the effects of EOX in hospitalized postoperative patients, evaluating both subjective (sleep quality, well-being) and objective (vital signs, metabolomics, microbiota composition) endpoints. The central hypothesis is that EOX induces a beneficial hormetic response-an adaptive reaction to mild environmental stressors-reflected by improved clinical recovery and biomarker modulation (e.g., succinate reduction, increased ATPase activity). The goal is to assess whether EOX can serve as an effective environmental intervention to support physiological healing and improve the quality of inpatient recovery.
- Being tested
- EOX Anion-Enriched Hospital Room
- Keywords
- Exposome, Bioavailable anions, Postoperative recovery, Mitochondrial function, Oxidative stress, Surgical inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOX Anion-Enriched Hospital RoomDevice
Participants are assigned to hospital rooms equipped with an operational EOX device, which actively regenerates air and releases bioavailable anions through cold atmospheric plasma. Exposure lasts for 96 hours postoperatively. The intervention aims to enhance postoperative recovery by modulating oxidative stress, improving mitochondrial function, and promoting sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Active mode | Active comparator | Device: EOX (active mode)
Dose/Duration: 96 hours of continuous exposure in the hospital room
Frequency: Continuous (24h/day during hospitalization) Receives: Device: EOX Anion-Enriched Hospital Room |
| Inactive mode | Sham comparator | Intervention:
Device: EOX (inactive mode)
Dose/Duration: 96 hours in the hospital room
Frequency: Device is present but non-functional (placebo exposure) Receives: Device: EOX Anion-Enriched Hospital Room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormetic clinical response associated with EOX exposure during the first 96 hours post-surgery
Evaluation of the adaptive (hormetic) biological response induced by anion-enriched air using EOX. This will be assessed through:
- 10% increase in plasma ATPase activity, and/or
- 10% decrease in plasma succinate levels, and/or
- 10% increase in uninterrupted sleep hours (based on sleep diary and nursing records), during the 96-hour postoperative hospital stay.
Measured: Baseline (day 0) to 96 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Response After SurgeryStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968000
- Sponsor's protocol ID
- EOX - BIOW
- Acronym
- EOX
- Status last verified
- Oct 2024
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cortazar OD, Megia-Macias A, Moreno S, Brun A, Gomez-Casado E. Vulnerability of SARS-CoV-2 and PR8 H1N1 virus to cold atmospheric plasma activated media. Sci Rep. 2022 Jan 7;12(1):263. doi: 10.1038/s41598-021-04360-y.
PubMed 34997166Antuna E, Carlos Bermejo-Millo J, Caso-Onzain E, Caso-Pelaez E, Potes Y, Coto-Montes A. Removal of Environmental Nanoparticles Increases Protein Synthesis and Energy Production in Healthy Humans. Front Bioeng Biotechnol. 2022 Feb 14;10:800011. doi: 10.3389/fbioe.2022.800011. eCollection 2022.
PubMed 35237574
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Controlled, Double-blind Study to Evaluate the Effect of the Exposome Anionic Enrichment System (Biow) on Hospital Recovery Quality, Clinical Response, and Sleep Quality in Postoperative Patients
- ClinicalTrials.gov ID
- NCT06968000
- Acronym / sponsor ID
- EOX / EOX - BIOW
- Keywords
- Exposome, Bioavailable anions, Postoperative recovery, Mitochondrial function, Oxidative stress, Surgical inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 May 2025 (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.
Airborne nanoparticle exposure is increasingly recognized as a significant contributor to oxidative stress, mitochondrial dysfunction, and low-grade systemic inflammation-factors that impair postoperative recovery. The World Health Organization and European initiatives such as the Human Exposome Project have highlighted the clinical importance of the exposome, defined as the totality of environmental exposures influencing health throughout life.
EOX is a CE-certified air regeneration system designed to modify the indoor exposome through a dual mechanism: advanced filtration and controlled emission of bioavailable anions using cold atmospheric plasma (CAP). Its multistage filter removes particulate matter, pathogens, and volatile organic compounds, while the anionic plasma phase modulates cellular oxidative balance and metabolic function.
Experimental and clinical data indicate that exposure to EOX improves mitochondrial efficiency, increases ATP production, and reduces oxidative protein damage. EOX has also been shown to influence molecular pathways involved in stress adaptation and repair, such as the HIF-1α-VEGF-EPO axis and protein synthesis signaling (e.g., mTOR-p70S6K). These mechanisms may collectively enhance tissue recovery, vascularization, and metabolic resilience in the postoperative setting.
The present study investigates the effects of EOX in hospitalized postoperative patients, evaluating both subjective (sleep quality, well-being) and objective (vital signs, metabolomics, microbiota composition) endpoints. The central hypothesis is that EOX induces a beneficial hormetic response-an adaptive reaction to mild environmental stressors-reflected by improved clinical recovery and biomarker modulation (e.g., succinate reduction, increased ATPase activity). The goal is to assess whether EOX can serve as an effective environmental intervention to support physiological healing and improve the quality of inpatient recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active mode | Active comparator | Device: EOX Anion-Enriched Hospital RoomDevice: EOX (active mode) Dose/Duration: 96 hours of continuous exposure in the hospital room Frequency: Continuous (24h/day during hospitalization) |
| Inactive mode | Sham comparator | Device: EOX Anion-Enriched Hospital RoomIntervention: Device: EOX (inactive mode) Dose/Duration: 96 hours in the hospital room Frequency: Device is present but non-functional (placebo exposure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years, regardless of sex.
- Undergoing elective general surgery, preferably hepatobiliary procedures.
- Hospitalized for at least 4 days postoperatively in Unit 69 (HUFJD).
- Able to provide written informed consent.
- Considered to have medium or high risk of oxidative stress or mitochondrial dysfunction.
Key exclusion criteria (5 listed)
- Surgery within the previous 6 months, either outpatient or inpatient.
- Diagnosed psychiatric or neurological disorders, including epilepsy.
- Active progressive cancer or chronic inflammatory disease.
- Cognitive impairment or inability to comply with study procedures.
- BMI ≥30 kg/m² (obesity class I or higher).
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 |
|---|---|---|
| EOX Anion-Enriched Hospital RoomParticipants are assigned to hospital rooms equipped with an operational EOX device, which actively regenerates air and releases bioavailable anions through cold atmospheric plasma. Exposure lasts for 96 hours postoperatively. The intervention aims to enhance postoperative recovery by modulating oxidative stress, improving mitochondrial function, and promoting sleep quality. | Device | Active mode, Inactive mode |
Primary outcome
Hormetic clinical response associated with EOX exposure during the first 96 hours post-surgery
Time frame: Baseline (day 0) to 96 hours post-intervention
Evaluation of the adaptive (hormetic) biological response induced by anion-enriched air using EOX. This will be assessed through: * 10% increase in plasma ATPase activity, and/or * 10% decrease in plasma succinate levels, and/or * 10% increase in uninterrupted sleep hours (based on sleep diary and nursing records), during the 96-hour postoperative hospital stay.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 34997166Cortazar OD, Megia-Macias A, Moreno S, Brun A, Gomez-Casado E. Vulnerability of SARS-CoV-2 and PR8 H1N1 virus to cold atmospheric plasma activated media. Sci Rep. 2022 Jan 7;12(1):263. doi: 10.1038/s41598-021-04360-y.
- Background: PubMed 35237574Antuna E, Carlos Bermejo-Millo J, Caso-Onzain E, Caso-Pelaez E, Potes Y, Coto-Montes A. Removal of Environmental Nanoparticles Increases Protein Synthesis and Energy Production in Healthy Humans. Front Bioeng Biotechnol. 2022 Feb 14;10:800011. doi: 10.3389/fbioe.2022.800011. eCollection 2022.
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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.
Fundacion Instituto de Investigacion Sanitaria Fjd
Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EOX Anion-Enriched Hospital Room in people with Inflammatory Response After Surgery and Postoperative Recovery, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 5 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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 Spain. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hormetic clinical response associated with EOX exposure during the first 96 hours post-surgery (time frame: Baseline (day 0) to 96 hours post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968000, which also lists 2 linked publications.
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 13 May 2025.