Narcolepsy - New Potential Treatment
The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease.
Device: Kinetic Oscillation Stimulation Device
Device: Kinetic Oscillation Stimulation Device in placebo mode
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
- Change in scale Epworth Sleep Scale (ESS) [ Time Frame: 15-21 days ] [ Designated as safety issue: No ]Change in ESS scale between baseline before treatment and at 15-21 days after treatment.
- Change in multiple sleep latency test (MSLT) [ Time Frame: 14 days ] [ Designated as safety issue: No ]Change in MSLT (mean sleep latency, number of sleep onset rapid eye movement (SOREM), and mean SOREM latency) between registration at baseline and 14 days after treatment.
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Active medical device||Device: Kinetic Oscillation Stimulation Device|
|Placebo Comparator: Inactive medical device||Device: Kinetic Oscillation Stimulation Device in placebo mode|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02077036
|Contact: Lars Hyllienmark, MD, PhD||+46-8-517 729 firstname.lastname@example.org|
|Karolinska University Hospital||Recruiting|
|Principal Investigator: Lars Hyllienmark, MD, PhD|