Association Between Systemic Ozone Therapy and Subjective Sleep Quality: A Prospective Pilot Clinical Study

Aim: It is known that poor sleep quality increases the likelihood of developing a wide range of chronic diseases. Furthermore, it is also known to lead to increased healthcare costs and reduced workforce productivity. The aim of this study is twofold: firstly, to investigate the effect of systemic ozone therapy on subjective sleep quality; secondly, to evaluate its safety profile.Material and Methods: This prospective, single-centre study comprised 51 patients (31 females, 20 males; mean age = 51.05 ± 11.85 years) receiving routine systemic ozone therapy—administered rectally—at an outpatient clinic specialising in Traditional and Complementary Medicine (TCM). The Pittsburgh Sleep Quality Index (PSQI) was utilised to assess sleep quality prior to and following a standardised 8-week ozone therapy protocol comprising 10 sessions.Results: PSQI scores were associated with significant improvements after treatment (mean change −2.72 ± 3.21; p < 0.001) and approached thresholds considered clinically significant in previous sleep research. GLMM analyses revealed significant main effects of time, age, gender, education, income, and comorbid health conditions on PSQI outcomes (all p < 0.05). No serious adverse events were observed throughout the study period.Conclusion: The current study demonstrated that systemic ozone therapy was associated with a significant improvement in subjective sleep quality, exhibiting a positive safety profile, albeit with a small pilot group and short follow-up period. These findings suggest that ozone therapy may be a promising complementary approach for managing sleep disorders, particularly in older adults and individuals with comorbid conditions. These findings are exploratory and preliminary.