Safe hydrogen inhalation in people with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label Phase 2 trial evaluating the safety and potential cognitive effects of daily 1-hour hydrogen gas inhalation in adults with mild cognitive impairment. Participants use a hydrogen inhalation device daily on workdays for a defined period, with safety monitored through questionnaires and standard health checks. Cognitive outcomes are assessed using recognized tools and language-related tests, while exploratory biomarkers like inflammation, antioxidant capacity, and metabolic measures are collected from blood samples. The trial is conducted at a single center in Ostrava, with industry-independent oversight and a lead sponsor from the University of Ostrava. Primary endpoints focus on inhalation safety and user-reported tolerability, while secondary endpoints explore biological and physiological indicators that could signal a broader effect on health status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients diagnosed with mild cognitive impairment (MCI) with an overall good health condition
* generally good health, with the ability to perform daily activities independently (modified Rankin score 0-2, Barthel index minimum 70 points)
* age between 50 and 80 years, ensuring inclusion of individuals within the typical risk range for cognitive decline
* a reliable study partner or caregiver who can provide accurate information about the participant's cognitive and functional abilities throughout the study
* stable medical condition, without major fluctuations in health status that could interfere with cognitive assessments
* signed informed consent, ensuring that participants understand the study protocol and potential risks

Exclusion Criteria:

* pregnancy or lactation, as the safety of hydrogen inhalation therapy in these populations has not been established
* use of medications or investigational treatments that could significantly affect cognitive function or interfere with study outcomes
* history of severe psychiatric disorders such as major depression, bipolar disorder, or schizophrenia, which may independently influence cognitive performance
* history of cerebrovascular events, including recent stroke or transient ischemic attack, which may confound cognitive outcomes
* severe cardiovascular diseases, including uncontrolled hypertension, recent myocardial infarction, or heart failure, that could pose additional risks during the study
* chronic kidney disease (stage 3 or higher), as impaired renal function may alter systemic metabolism and affect the study's findings
* significant respiratory disorders, such as severe chronic obstructive pulmonary disease (COPD) or restrictive lung diseases, that could impact the safety of hydrogen inhalation
* known hypersensitivity or allergic reactions to materials used in the hydrogen delivery system, such as nasal cannulas or facial masks
* recent participation in another clinical trial within the past 90 days, to prevent potential interactions and ensure unbiased study results

Where it's running

• Cerebrovaskularni poradna s.r.o.
  Ostrava, Moravian-Silesian Region, Czechia Recruiting

Study contacts

• Study coordinator: David Skoloudik, M.D., Ph.D.
• Email: skoloudik@email.cz
• Phone: +420739782970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.