数字治疗方案 sinCephalea 预防偶发性偏头痛患者偏头痛的疗效：一项数字、随机、开放标签、标准治疗对照试验的研究方案。
Efficacy of the Digital Therapeutic sinCephalea in the prophylaxis of migraine in patients with episodic migraine: study protocol for a digital, randomized, open-label, standard treatment controlled trial.
机构信息
Institute of Nutritional Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck & University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Perfood GmbH, Am Spargelhof 2, Lübeck, Germany.
出版信息
Trials. 2022 Dec 12;23(1):997. doi: 10.1186/s13063-022-06933-2.
BACKGROUND
The German government implemented the Digital Healthcare Act in order to bring Digital Therapeutics into standard medical care. This is one of the first regulatory pathways to reimbursement for Digital Therapeutics (DTx). The Digital Therapeutic sinCephalea is intended to act as a prophylactic treatment of migraine by reducing the migraine days. For this, sinCephalea determines personalized nutritional recommendations using continuous glucose monitoring (CGM) data and enables the patients to follow a personalized low-glycemic nutrition. Migraine is a headache disorder with the highest socioeconomic burden. Emerging evidence shows that CGM-based personalized nutritional recommendations are of prophylactic use in episodic migraine. However, prospective data are yet missing to demonstrate clinical effectiveness. This study is designed to fill this gap.
METHODS
Patients between 18 and 65 years of age with proven migraine and a minimal disease severity of 3 migraine days per month are included. After a 4-week baseline phase as a pre-study, patients are randomized to the DTx intervention or a waiting-list control. The objective of the study is to show differences between the intervention and control groups regarding the change of migraine symptoms and of effects of migraine on daily life.
DISCUSSION
To our knowledge, this is the first systematic clinical trial with a fully digital program to enable patients with migraine to follow a personalized low-glycemic nutrition in order to reduce their number of migraine days and the migraine-induced impact on daily life. Designing a clinical study using a digital intervention includes some obstacles, which are addressed in this study approach.
TRIAL REGISTRATION
German Registry of Clinical Studies (Deutsches Register Klinischer Studien) DRKS-ID DRKS00024657. Registered on March 8, 2021.
背景
德国政府实施了《数字医疗法案》，旨在将数字疗法纳入标准医疗服务。这是数字疗法（DTx）报销的首批监管途径之一。sinCephalea 数字疗法旨在通过减少偏头痛天数来预防偏头痛。为此，sinCephalea 使用连续血糖监测（CGM）数据确定个性化营养建议，并使患者能够遵循个性化低升糖指数营养方案。偏头痛是一种头痛障碍，具有最高的社会经济负担。新出现的证据表明，基于 CGM 的个性化营养建议对偶发性偏头痛具有预防作用。然而，目前还缺乏前瞻性数据来证明其临床疗效。本研究旨在填补这一空白。
方法
纳入年龄在 18 至 65 岁之间、已确诊偏头痛且每月偏头痛发作至少 3 天的患者。在作为预研究的 4 周基线期后，患者被随机分配到 DTx 干预组或等待名单对照组。该研究的目的是显示干预组和对照组之间在偏头痛症状变化和偏头痛对日常生活影响方面的差异。
讨论
据我们所知，这是首个使用全数字化方案的系统临床试验，使偏头痛患者能够遵循个性化低升糖指数营养方案，以减少偏头痛发作天数和偏头痛对日常生活的影响。使用数字干预措施设计临床试验包括一些障碍，本研究方法解决了这些障碍。
试验注册
德国临床试验注册处（Deutsches Register Klinischer Studien）DRKS-ID DRKS00024657。于 2021 年 3 月 8 日注册。
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