MedTrace Logo

Cognitive Frailty and Oxygen-ozone Therapy

NCT06071611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-12-26

No results posted yet for this study

Summary

As the world's population age, frailty is moving to the forefront of health and medical research and may become one of the world's most serious health issues. Understanding frailty prevention and treatment becomes even more crucial in order to reduce national healthcare costs. Oxygen-Ozone (O2-O3) therapy is a no-invasive/no-pharmacological and low cost procedure based on the therapeutic effects of low O3 concentrations, already used in medicine as an alternative/adjuvant treatment for different diseases and in the elderly. This project is the first pilot double blind randomized controlled trial where a group of elderly frail subjects are stratified as untreated (air), treated with pure O2 and treated with a mixture of O2-O3. The biological corollary will be transcriptomics, proteomics and also cognitive impairment assessment at baseline and after treatment. An algorithm combining these data will identify biomarkers of the response to O2-O3 therapy.

Conditions

  • Cognitive Frailty

Interventions

OTHER

Experimental: Oxygen-Ozone (O2-O3)

Oxygen-Ozone (O2-O3) treatment by rectal insufflations for 5 weeks (3 sessions for week).

OTHER

Active Comparator: Oxygen (O2)

Oxygen (O2) treatment by rectal insufflations for 5 weeks (3 sessions for week).

OTHER

Placebo Comparator: Placebo (Air)

Air treatment by rectal insufflations for 5 weeks (3 sessions for week).

Sponsors & Collaborators

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Cristina Geroldi, MD · IRCCS Centro San Giovanni di Dio Fatebenefratelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2022-11-02
Completion
2023-11-17

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06071611 on ClinicalTrials.gov