Narcolepsy - New Potential Treatment

NCT ID: NCT02077036

Last Updated: 2014-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Narcolepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Study Groups

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Active medical device

Group Type EXPERIMENTAL

Kinetic Oscillation Stimulation Device

Intervention Type DEVICE

Inactive medical device

Group Type PLACEBO_COMPARATOR

Kinetic Oscillation Stimulation Device in placebo mode

Intervention Type DEVICE

Interventions

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Kinetic Oscillation Stimulation Device

Intervention Type DEVICE

Kinetic Oscillation Stimulation Device in placebo mode

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Hyllienmark

Associate professor, consultant in neurology and clinical neurophysiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Lars Hyllienmark, MD, PhD

Role: CONTACT

+46-8-517 729 79

Other Identifiers

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nervus11

Identifier Type: -

Identifier Source: org_study_id

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