Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-02-01
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patient with narcolepsy treated with vagus nerve stimulation
Patient with narcolepsy treated with vagus nerve stimulation
Implantation of vagus nerve stimulation according to clinical indication
no interventions, only observation
Patient without narcolepsy treated with vagus nerve stimulation
Patient without narcolepsy treated with vagus nerve stimulation
Implantation of vagus nerve stimulation according to clinical indication
no interventions, only observation
Interventions
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Implantation of vagus nerve stimulation according to clinical indication
no interventions, only observation
Eligibility Criteria
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Inclusion Criteria
* patients with other neurological sleep disorders
Exclusion Criteria
* patients who cannot provide informed consent and don't have a legal guardian
18 Years
120 Years
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Dr. Yaroslav Winter
Head of Mainz Comprehensive Epilepsy and Sleep Medicine Center
Locations
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Mainz Comprehensive Epilepsy and Sleep Medicine Center
Mainz, Rhineland-Palatinate, Germany
Countries
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Facility Contacts
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References
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Winter Y, Lang C, Kallweit U, Apel D, Fleischer V, Ellwardt E, Groppa S. Pitolisant-supported bridging during drug holidays to deal with tolerance to modafinil in patients with narcolepsy. Sleep Med. 2023 Dec;112:116-121. doi: 10.1016/j.sleep.2023.10.005. Epub 2023 Oct 9.
Other Identifiers
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MAINZ-SLEEPREG
Identifier Type: -
Identifier Source: org_study_id
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