Narcolepsy - New Potential Treatment

February 28, 2014 updated by: Lars Hyllienmark, Karolinska University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Principal Investigator:
          • Lars Hyllienmark, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15-21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nervus11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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