Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvatore Allende, 84081 Baronissi, Italy.
Department of Neurosurgery, Aix Marseille University, APHM, UH Timone, 13005 Marseille, France.
Med Sci (Basel). 2023 Dec 28;12(1):2. doi: 10.3390/medsci12010002.
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.
睡眠对整体健康至关重要，但各种睡眠障碍会破坏正常的睡眠模式，影响睡眠的持续时间、质量和时间。这项初步研究调查了一种食品补充剂（SPINOFF）对 41 名参与者（平均年龄：45.3 岁）的睡眠质量和心理健康的影响。初步评估显示存在睡眠障碍（匹兹堡睡眠质量指数-PSQI-平均得分为 8.2）和失眠症状（失眠严重程度指数-ISI-平均得分为 12.7）。心理健康评估显示存在心理困扰（Dass-21 抑郁平均得分为 4.2，焦虑平均得分为 6.9，压力平均得分为 11.6，总平均得分为 22.7）。本研究使用智能手表（HELO HEALTH）通过夜间觉醒次数（ApN）评估睡眠连续性，并分两个阶段进行研究：基线（T0）和 30 天治疗后（T1）（阶段 A）。本研究未使用安慰剂对照。30 天后（阶段 B），选择 21 名患者进行重新评估。11 名患者继续治疗 30 天（T2），而 10 名患者停止治疗。干预后，我们观察到睡眠质量和心理困扰显著改善。SPINOFF 补充剂显著降低了 PSQI 评分（22.4%），表明睡眠质量得到改善。此外，ISI 评分下降了 19.6%，表明失眠症状有所减轻。此外，总体心理困扰降低了 19.5%，表明心理健康状况得到改善。在第二阶段，继续治疗的参与者经历了更显著的改善，PSQI 评分平均降低了 0.8 分（±0.9），ISI 评分平均降低了 0.9 分。我们的研究结果表明，SPINOFF 补充剂有可能有效解决研究人群的睡眠障碍和心理困扰。
