Narcolepsy - New Potential Treatment

N/AUnknownNCT02077036

Karolinska University Hospital30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Narcolepsy

Interventions

Kinetic Oscillation Stimulation DeviceDEVICE

Kinetic Oscillation Stimulation Device in placebo modeDEVICE

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Outcomes

Primary Outcomes

Change in scale Epworth Sleep Scale (ESS)

Change in ESS scale between baseline before treatment and at 15-21 days after treatment.

Time frame: 15-21 days

Secondary Outcomes

Change in multiple sleep latency test (MSLT)

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.

Time frame: 14 days

Central Contacts

Lars Hyllienmark, MD, PhD

CONTACT

+46-8-517 729 79 lars.hyllienmark@karolinska.se

Data from ClinicalTrials.gov

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