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Narcolepsy - New Potential Treatment

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ClinicalTrials.gov Identifier: NCT02077036
Recruitment Status : Unknown
Verified February 2014 by Lars Hyllienmark, Karolinska University Hospital.
Recruitment status was:  Recruiting
First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Lars Hyllienmark, Karolinska University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Narcolepsy Device: Kinetic Oscillation Stimulation Device Device: Kinetic Oscillation Stimulation Device in placebo mode Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active medical device Device: Kinetic Oscillation Stimulation Device
Placebo Comparator: Inactive medical device Device: Kinetic Oscillation Stimulation Device in placebo mode



Primary Outcome Measures :
  1. Change in scale Epworth Sleep Scale (ESS) [ Time Frame: 15-21 days ]
    Change in ESS scale between baseline before treatment and at 15-21 days after treatment.


Secondary Outcome Measures :
  1. Change in multiple sleep latency test (MSLT) [ Time Frame: 14 days ]
    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.



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • 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:

  • Reduced cognitive function
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077036


Contacts
Contact: Lars Hyllienmark, MD, PhD +46-8-517 729 79 lars.hyllienmark@karolinska.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Principal Investigator: Lars Hyllienmark, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital

Responsible Party: Lars Hyllienmark, Associate professor, consultant in neurology and clinical neurophysiology, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02077036     History of Changes
Other Study ID Numbers: nervus11
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders