背景:在全球范围内,人口向人口老龄化的转变导致医疗保健系统面临重大挑战,特别是由于老年人中导致多重用药的多发病率增加。同时,睡眠障碍是老年人的常见主诉。用药物治疗的治疗通常导致副作用,引起高度依赖性的可能性。在此背景下,非常需要探索非药物治疗方法。这项研究的目的是评估针灸和音乐疗法的有效性,无论是单独还是作为多模式疗法,用于治疗70岁及以上人群的睡眠障碍。
方法:我们进行了一项验证性随机对照试验,采用双因子研究设计。共有n=100的老年人接受了与年龄相关的睡眠障碍的循证标准护理信息。除此之外,患者被随机分为四组,每组25人接受针灸治疗,接受单弦的音乐疗法,针灸和音乐疗法的多模式疗法,或者没有进一步的治疗。该研究的主要结果测量是匹兹堡睡眠质量指数(PSQI)(全球评分)评估的睡眠质量改善,在干预结束时。此外,抑郁评分(老年抑郁量表),与健康相关的生活质量(短期健康调查-12),通过心率变异性测量的神经营养活动,并收集安全性数据作为次要结局.使用混合方法方法,将进行定性过程评估以补充定量数据。
结论:该研究正在进行中,预计在2024年4月招募最后一名患者。研究结果可为老年人睡眠障碍非药物干预措施的有效性提供有价值的见解,为老年保健提供更个性化和更全面的方法。
背景:德国临床试验注册(DRKS00031886)。
BACKGROUND: Globally, the demographic shift towards an aging population leads to significant challenges in healthcare systems, specifically due to an increasing incidence of multimorbidity resulting in polypharmacy among the elderly. Simultaneously, sleep disorders are a common complaint for elderly people. A treatment with pharmacological therapies often leads to side effects causing a high potential for dependency. Within this context, there is a high need to explore non-pharmacological therapeutic approaches. The purpose of this study is to evaluate the effectiveness of acupuncture and music therapy, both individually and combined as a multimodal therapy, in the treatment of sleep disorders in individuals aged 70 years and older.
METHODS: We conduct a confirmatory randomized controlled trial using a two-factorial study design. A total of n = 100 elderly people receive evidence-based standard care information for age-related sleep disorders. Beyond that, patients are randomly assigned into four groups of n = 25 each to receive acupuncture, receptive music therapy with a monochord, multimodal therapy with both acupuncture and music therapy, or no further therapy. The study\'s primary outcome measurement is the improvement in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (global score), at the end of intervention. Additionally, depression scores (Geriatric Depression Scale), health-related quality of life (Short-Form-Health Survey-12), neurovegetative activity measured via heart rate variability, and safety data are collected as secondary outcomes. Using a mixed-methods approach, a qualitative process evaluation will be conducted to complement the quantitative data.
CONCLUSIONS: The study is ongoing and the last patient in is expected to be enrolled in April 2024. The results can provide valuable insights into the effectiveness of non-pharmacological interventions for sleep disorders among the elderly, contributing to a more personalized and holistic approach in geriatric healthcare.
BACKGROUND: German Clinical Trials Register (DRKS00031886).