Narcolepsy - New Potential Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by Karolinska University Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Lars Hyllienmark, Karolinska University Hospital Identifier:
First received: February 11, 2014
Last updated: February 28, 2014
Last verified: February 2014
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 Intervention
Device: Kinetic Oscillation Stimulation Device
Device: Kinetic Oscillation Stimulation Device in placebo mode

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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 Enrollment: 30
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active medical device Device: Kinetic Oscillation Stimulation Device
Placebo Comparator: Inactive medical device Device: Kinetic Oscillation Stimulation Device in placebo mode


Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02077036

Contact: Lars Hyllienmark, MD, PhD +46-8-517 729 79

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

Responsible Party: Lars Hyllienmark, Associate professor, consultant in neurology and clinical neurophysiology, Karolinska University Hospital Identifier: NCT02077036     History of Changes
Other Study ID Numbers: nervus11 
Study First Received: February 11, 2014
Last Updated: February 28, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Mental Disorders
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on May 25, 2016