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Narcolepsy - New Potential Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Lars Hyllienmark, Karolinska University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02077036
First Posted: March 4, 2014
Last Update Posted: March 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lars Hyllienmark, Karolinska University Hospital
  Purpose
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
Narcolepsy Device: Kinetic Oscillation Stimulation Device Device: Kinetic Oscillation Stimulation Device in placebo mode

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by NLM:


Further study details as provided by Lars Hyllienmark, Karolinska University Hospital:

Primary Outcome Measures:
  • 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:
  • 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.


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: February 11, 2014
First Posted: March 4, 2014
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


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