Effectiveness of the digital health application sinCephalea in theprophylaxis of migraine days in patients with episodic migrainesover a period of twelve weeks - sinCephalea

Perfood GmbH0 个研究点目标入组 842 人开始时间: 2021年3月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Diagnosis is made or confirmed by a doctor
•An average of 3 or more migraine days per 4 weeks.
•Ability to differentiate between migraines and other headaches.
•Minimum age 18 years and maximum age 65 years (at the time of inclusion).
•Migraines has started before the age of 50 and persists for at least 12 months.
•Sufficient knowledge of German to understand the study documents.
•Use of an Android (from version 5.1) or iOS smartphone (from version 12.0) (use of thesinCephalea app required).
•Sufficient intellectual ability to consent and participate in the study.
•Ability and willingness to give consent.
•Written consent.

•Use of another Perfood GmbH product with a blood sugar analysis within the last 24 months.
•Pregnancy, current desire to have children, breastfeeding.
•Evidence of another type of headache (Chronic migraines according to Chapter 1 of ICHD-3; primary headache according to ICHD-3 chapters 3 and 4; Tension-type headache (ICHD-3, Chapter 2) if thisheadache has accounted for more than 50% of the headache days per 4 weeks within the last 3 months; Headache from drug overuse)
•Complicated migraine attacks with impairing (e.g. hemiplegic) and / or long-lasting auras aftera migraine cerebral infarction.
•Change of prophylactic medication or use of an alternative migraine app (except for the purerecording of headaches) within the last 12 weeks.
•Drug prophylaxis of migraines with more than one preparation.
•Use of acupuncture as non-drug prophylactic treatment method
•Diagnosis of malignant disease within the last 3 years or while therapy is ongoing.
•Insulin-treated diabetes mellitus.
•Psychiatric illness (with the exception of stable depression) that necessitates drug therapy orinpatient therapy within the last 12 weeks.
•Other diseases that are treated with drug therapy that are also used in the drug prophylaxis ofmigraines
•Eating disorder (binge eating, anorexia nervosa, bulimia).
•Participation in another clinicial study at the same time.

发起方

Perfood GmbH