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

Torsten Schröder; Hanna C.B. Brudermann; Gianna Kühn; Christian Sina; Diamant Thaçi; Matthias Nitschke; Inke R. König

doi:10.1186/s13063-022-06933-2

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

Torsten Schröder, Hanna C.B. Brudermann, Gianna Kühn, Christian Sina, Diamant Thaçi, Matthias Nitschke, Inke R. König^*

^*Korrespondierende/r Autor/-in für diese Arbeit

Perfood GmbH

3 Zitate (Scopus)

Abstract

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.

Originalsprache	Englisch
Aufsatznummer	997
Zeitschrift	Trials
Jahrgang	23
Ausgabenummer	1
ISSN	1745-6215
DOIs	https://doi.org/10.1186/s13063-022-06933-2
Publikationsstatus	Veröffentlicht - 12.2022

Fördermittel

The study is sponsored and completely funded by Perfood GmbH, Am Spargelhof 2, D-23554 Lübeck, Germany. The roles of the sponsor, study site, statistics, and monitoring are clearly organized and pre-defined. The sponsor is responsible for study design, recruitment, and data monitoring. Patient data are not communicated to the sponsor, so all data are handled with pseudonyms only the study site can encrypt. However, the patients have to use an email address to use the app. All reports and publications concerning the study will be coordinated with the responsible biostatistician of the IMBS to avoid misinterpretation of statistical results.

UN SDGs

Dieser Output leistet einen Beitrag zu folgendem(n) Ziel(en) für nachhaltige Entwicklung

SDG 3 – Gesundheit und Wohlergehen
SDG 10 – Weniger Ungleichheiten

Dokumente

10.1186/s13063-022-06933-2

Weitere Links

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Zitieren

Schröder, T., Brudermann, H. C. B., Kühn, G., Sina, C., Thaçi, D., Nitschke, M., & König, I. R. (2022). 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. Trials, 23(1), Artikel 997. https://doi.org/10.1186/s13063-022-06933-2

@article{54c1d3130b4e41b99b5a193bc9ac42ae,

title = "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",

abstract = "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.",

author = "Torsten Schr{\"o}der and Brudermann, \{Hanna C.B.\} and Gianna K{\"u}hn and Christian Sina and Diamant Tha{\c c}i and Matthias Nitschke and K{\"o}nig, \{Inke R.\}",

note = "Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s13063-022-06933-2",

language = "English",

volume = "23",

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Schröder, T, Brudermann, HCB, Kühn, G, Sina, C , Thaçi, D, Nitschke, M & König, IR 2022, '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', Trials, Jg. 23, Nr. 1, 997. https://doi.org/10.1186/s13063-022-06933-2

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. / Schröder, Torsten; Brudermann, Hanna C.B.; Kühn, Gianna et al.
in: Trials, Jahrgang 23, Nr. 1, 997, 12.2022.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Efficacy of the Digital Therapeutic sinCephalea in the prophylaxis of migraine in patients with episodic migraine

T2 - study protocol for a digital, randomized, open-label, standard treatment controlled trial

AU - Schröder, Torsten

AU - Brudermann, Hanna C.B.

AU - Kühn, Gianna

AU - Sina, Christian

AU - Thaçi, Diamant

AU - Nitschke, Matthias

AU - König, Inke R.

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85143655141

U2 - 10.1186/s13063-022-06933-2

DO - 10.1186/s13063-022-06933-2

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