Enhancing Sleep Quality: Assessing the Efficacy of a Fixed Combination of Linden, Hawthorn, Vitamin B1, and Melatonin.

Sleep is essential for overall health, yet various sleep disorders disrupt normal sleep patterns, affecting duration, quality, and timing. This pilot study investigate the impact of a food supplement (SPINOFF) on both sleep quality and mental well-being in 41 participants (mean age: 45.3 years). Initial assessments revealed sleep disturbances (Pittsburgh Sleep Quality Index-PSQ-mean score: 8.2) and insomnia symptoms (Insomnia Severity Index-ISI- mean score: 12.7). Mental health assessments showed psychological distress (Dass-21 Depression mean score: 4.2, Anxiety mean score: 6.9, Stress mean score: 11.6, Total mean score: 22.7). This study assessed sleep continuity using Awakenings per Night (ApN) via a smartwatch (HELO HEALTH) and conducted the study in two phases: baseline (T0) and after 30 days of treatment (T1) (Phase A). No placebo-control was used in this study. After 30 days (Phase B), 21 patients were selected for reassessment. Eleven continued treatment for another 30 days (T2), while ten discontinued. Following the intervention, we observed remarkable improvements in sleep quality and mental distress. The SPINOFF supplement significantly reduced the PSQI scores (22.4%), indicating enhanced sleep quality. Additionally, there was a 19.6% decrease in ISI scores, demonstrating a reduction in insomnia symptoms. Moreover, overall psychological distress decreased by 19.5% signifying improved psychological well-being. In the second phase, participants who continued treatment experienced more substantial improvements, with a mean decrease of 0.8 points in PSQI scores (±0.9) and a mean decrease of 0.9 points in ISI scores. Our findings suggest that the SPINOFF supplement has the potential to effectively address both sleep disturbances and psychological distress in our study population.