Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery and Sleep Quality in Postoperative Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EOX Anion-Enriched Hospital Room.
- Who it may be relevant to
- Registry conditions: Inflammatory Response After Surgery, Postoperative Recovery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device EOX Anion-Enriched Hospital Room
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 outcome measures
- Hormetic clinical response associated with EOX exposure during the first 96 hours post-surgery [Time frame: Baseline (day 0) to 96 hours post-intervention]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Fundacion Instituto de Investigacion Sanitaria Fjd — Madrid
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. PMID 34997166
- Antuna 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. PMID 35237574
Identifiers
NCT: NCT06968000 · EOX - BIOW