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Search / Trial NCT06968000

Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery and Sleep Quality in Postoperative Patients

Launched by INSTITUTO DE INVESTIGACIÓN SANITARIA DE LA FUNDACIÓN JIMÉNEZ DÍAZ · May 5, 2025

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Exposome Bioavailable Anions Postoperative Recovery Mitochondrial Function Oxidative Stress Surgical Inflammation

ClinConnect Summary

This clinical trial is studying a new air regeneration system called EOX to see if it can help patients recover better and sleep more soundly after surgery. Researchers believe that exposure to certain environmental factors, like tiny particles in the air, can negatively impact recovery by causing inflammation and stress in the body. The EOX system works by filtering the air and releasing beneficial particles that may improve how our cells function and help the body heal after surgery.

To participate in the trial, you need to be an adult over 18 years old, scheduled for certain types of elective surgeries, and expected to stay in the hospital for at least four days after the operation. You should also be at medium or high risk for issues related to oxidative stress, which can happen after surgery. Participants will be monitored for their recovery progress, including how well they sleep and feel, and some biological measurements will be taken to see how the treatment affects their healing. If you're interested, please talk to your healthcare provider for more information!

Gender

ALL

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).

About Instituto De Investigación Sanitaria De La Fundación Jiménez Díaz

The Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (IIS-FJD) is a leading biomedical research institute based in Madrid, Spain, dedicated to advancing healthcare through innovative research and clinical trials. Affiliated with the Fundación Jiménez Díaz Hospital, IIS-FJD focuses on translating scientific discoveries into effective treatments and therapies, fostering collaboration among researchers, healthcare professionals, and academic institutions. With a commitment to improving patient outcomes, the institute emphasizes interdisciplinary approaches in areas such as oncology, cardiovascular health, and rare diseases, making significant contributions to the field of medical research and enhancing the quality of care provided to patients.

Locations

Madrid, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported