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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UNKNOWN
NA
30 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Active medical device
Kinetic Oscillation Stimulation Device
Inactive medical device
Kinetic Oscillation Stimulation Device in placebo mode
Interventions
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Kinetic Oscillation Stimulation Device
Kinetic Oscillation Stimulation Device in placebo mode
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with narcolepsy (diagnose code G47.4)
* 16 - 60 years of age
* MSLT has shown hypersomnia (sleeping latency \< 8 min) \& 1 episode REM
* HLA-type associated with increased occurrence of narcolepsy
Exclusion Criteria
* Other relevant organ disease (that could affect the study results or put the patient at risk)
* Ongoing bacterial infection in the nose
* Comorbidity that can increase the risk of bleeding
* Has received treatment with an implantable stimulator or other implantable product in the head and / or in the neck
* Known pronounced septal deviation
* Known allergy to polyvinylchloride or medicinal liquid paraffin
* Women not using adequate contraceptives
* Participated in a clinical investigational drug trial within the previous 30 days
16 Years
60 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Responsible Party
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Lars Hyllienmark
Associate professor, consultant in neurology and clinical neurophysiology
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Other Identifiers
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nervus11
Identifier Type: -
Identifier Source: org_study_id
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