Effect of Anionic Exposome Enrichment 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
Run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT06968000 · Data updated 2026-11-12
This study is testing if breathing in a special air system with added healthy particles can help patients recovering from liver surgery sleep better and heal faster.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT06968000 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are undergoing elective general surgery and are at medium or high risk for oxidative stress or mitochondrial dysfunction.
✕Probably not a fit
Patients who have undergone surgery within the past six months, have active progressive cancer, chronic inflammatory diseases, or significant cognitive impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the impact of an air regeneration system that enriches the indoor environment with bioavailable anions on the recovery and sleep quality of postoperative patients. The study focuses on patients undergoing elective general surgery, particularly hepatobiliary procedures, and aims to assess how this intervention can mitigate oxidative stress and improve mitochondrial function. Participants will be hospitalized for at least four days post-surgery in a specially designed room equipped with the EOX system, which utilizes advanced filtration and cold atmospheric plasma technology. The trial is double-blind, ensuring that neither the participants nor the researchers know who is receiving the active treatment versus a control.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance postoperative recovery and sleep quality for patients, potentially leading to faster healing and reduced complications.
How similar studies have gone: While the concept of modifying the exposome for health benefits is gaining traction, this specific approach using anionic enrichment in a postoperative setting is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Fundacion Instituto de Investigacion Sanitaria Fjd
Madrid, Madrid, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.