Effect of Anionic Exposome Enrichment on Recovery and Sleep Quality in Postoperative Patients
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
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 |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06968000 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madrid, Madrid
- Fundacion Instituto de Investigacion Sanitaria Fjd — Madrid, Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.