Narcolepsy - New Potential Treatment

Not Applicable

• Conditions: Narcolepsy
• Interventions: Device: Kinetic Oscillation Stimulation Device in placebo mode; Device: Kinetic Oscillation Stimulation Device

• Registration Number: NCT02077036
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-28
• Last Update Submitted: 2014-02-28
• Study First Posted: 2014-03-04
• Last Update Posted: 2014-03-04
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inactive medical device	Kinetic Oscillation Stimulation Device in placebo mode	-
Active medical device	Kinetic Oscillation Stimulation Device	-

Primary Outcome Measures

Name	Time	Method
Change in scale Epworth Sleep Scale (ESS)	15-21 days	Change in ESS scale between baseline before treatment and at 15-21 days after treatment.

Secondary Outcome Measures

Name	Time	Method
Change in multiple sleep latency test (MSLT)	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.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden