Clinical trial NCT06968000: Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery and Sleep Quality in Postoperative Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Inflammatory Response After Surgery
Postoperative Recovery
Keywords: Exposome
Bioavailable anions
Postoperative recovery
Mitochondrial function
Oxidative stress
Surgical inflammation
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


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).

Primary outcomes:
measure: Hormetic clinical response associated with EOX exposure during the first 96 hours post-surgery
timeFrame: Baseline (day 0) to 96 hours post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Instituto de Investigacion Sanitaria Fjd
Study officials:
References:
citation: 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.
citation: 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.