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NCT Number: NCT06968000

Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fundacion Instituto de Investigacion Sanitaria Fjd

Madrid, 28040, Spain

Location status: Recruiting

Location contact

Damian García-Olmo, Full prof.

SUB_INVESTIGATOR

Eduardo Serrano

SUB_INVESTIGATOR

Gloria Ariel

SUB_INVESTIGATOR

Hector Guadalajara, MD, PhD

PRINCIPAL_INVESTIGATOR

Héctor Guadalajara, MD, PhD

CONTACT

[email protected]

0034 + 915504800 ext. 4331

Miguel Andres

SUB_INVESTIGATOR

Miguel Leon, MD, PhD

SUB_INVESTIGATOR

Pedro Villarejo, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

EOX Anion-Enriched Hospital Room

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study 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

Acronym: EOX

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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