NCT07757542 · Phase 2 · RECRUITING
Safety Assessment of H2 Inhalation in Patients With Mild Cognitive Impairment
This trial is testing whether breathing molecular hydrogen gas for one hour a day, five days a week, is safe and tolerable for people with mild cognitive impairment. Researchers will also take a preliminary look at cognitive test scores and blood markers like inflammation. It is a Phase 2 pilot study — meaning it is an early-stage safety check with 30 participants, not a definitive test of whether hydrogen inhalation works.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-11