EU-NN is running a scientific database to collect prospective data on narcolepsy and related sleep disorders. The EU-NN database is conceived as a long-term project to integrate clinical and preclinical data, including sleep studies and biosamples (blood and cerebrospinal fluid) at inclusion and at regular follow-up visits.
The goals of the EU-NN database are
– to provide a larger clinical data set and sufficient numbers of biosamples for future research.
– to obtain natural history data on a wide spectrum of narcolepsy-patients and of patients suffering from related sleep disorders.
– to relate phenotypical characteristics with genetic factors and biomarkers
– to expedite identification and recruitment of participants for future observational and interventional trials
Database access
The narcolepsy-network-system is implemented as a web-application (https://redcap.ctu.unibe.ch). Only EU-NN members will have access to data of their own study site. Login information will be provided upon application for EU-NN members. By entering data each participating sleep-center will attribute a case with a patient-code facilitating local identification of a patient at the institution only. Any site investigator in the database is allowed to see only data on participants of his/her study site.
Inclusion criteria
Individuals who fulfil the criteria of CNS hypersomnias as defined by International Classification of Sleep Disorders (ICSD-2) are potentially eligible. Patients have to sign written informed consent which has been approved by local ethical committee (link to template). Patients under the age of 18 years at the time of enrolment have to bring written informed consent from one parent/legal representative. Following guidelines will be considered:
1) < age of 7 years: written parental permission
2) 7-12 years of age: written parental consent and verbal agreement of the child which has to be documented
3) 13-15/17 years of age: written parental permission and written consent of the child
Exclusion criteria
Subjects who are unable to understand the study protocol or unable to give informed consent and have no legal representative.
Data policy
The access to the database and to the biosamples is regulated by the policies of EU-NN.
The EU-NN Steering Committee of the database is responsible for overseeing the monitoring and data quality control procedures. Investigators, whose projects where approved by the scientific review committee of EU-NN receive a pertinent extract out of the database. By order of the Steering Committee of the database, Central Coordination is permitted to statistically evaluate the whole dataset. The database is saved on a server.
Data security
The EU-NN has several strict rules to maintain integrity, and confidentiality of the database and to prevent unauthorized persons to access to uncoded medical or personal information. All communication between clients (web-browsers) and the server is SSL-encrypted according to the current standards implemented in web-browsers. The application is hosted at a professional data-center offering high availability and security. The host systems are Linux based.
Administrative and financial responsibilities
The EU-NN is owner of the database and responsible for all database-administration.
Each participating center contributes financial support for database maintenance.
The investigator is the local person responsible for the patients` recruitment at each centre and guarantees adequate medical care of the participant during the study. He/she must follow Good Clinical Practice “GCP-guidelines”. Central Coordination of EU-NN has to take care that monitoring is executed according to the principles of GCP and for supplying trained personal for this purpose. Central coordination has access to all centres for plausibility checks, quality control, and monitoring.
Researchers interested in obtaining data or biosamples for further analysis have to submit outlines of their research projects to the Scientific Review Board of the EU-NN. The Board- members will decide whether to approve or reject the project. Once a study has been approved, the applicant has to confirm in written form to comply with the data access and publication policies of the EU-NN and will provide a short abstract of the approved proposal for display at EU-NN-homepage.