Methodology and Preliminary Observations on Hypoxic–Hyperoxic Therapy Using the CellOxy System in Healthy Volunteers: A Sin-gle-Arm Pilot Study

Intermittent hypoxic–hyperoxic exposure therapy (IHHT) has become a promising approach in adaptive training that may stimulate mitochondrial biogenesis, improve redox homeostasis, and enhance cardiopulmonary efficiency. However, standardized clinical protocols and safety validation in healthy populations are still insufficient. Objective: This prospective pilot study assessed the feasibility, safety, and physiological tolerance of the IHHT using the CellOxy intelligent system in healthy volunteers. The study was conducted at the Teaching Emergency Hospital “Bagdasar-Arseni” (SCUBA), with approval from the institution’s Bioethics Committee. Healthy adult volunteers underwent structured IHHT consisting of 4 cycles of hypoxia [Fraction of Inspired Oxygen (FiO2) 9–16%, titrated in order to reach a target oxygen saturation (SpO2) ~ 85%], alternating with 3–4 cycles of hyperoxia (FiO2 33–37%), each hypoxic cycle lasting 4 minutes and each hyperoxic phase 2 minutes; one session lasted approximately 30 minutes. Sessions were repeated 2–3 times per week for one month. Cardiopulmonary exercise testing (CPET) and complete blood count (CBC) analyses were performed at baseline and after the intervention. All participants completed the intervention without any adverse events. Preliminary data indicate improved exercise tolerance and stable hematological parameters, consistent with good physiological adaptability. The CellOxy-based IHHT protocol was safe and well-tolerated in healthy volunteers. This adjunctive therapy may be applicable in neuro- and cardiopulmonary rehabilitation. Further controlled studies with extended biomarker assessment are necessary.