Narcolepsy - New Potential Treatment

Narcolepsy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02077036
• Other study ID #: nervus11
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2014
• Last updated: February 28, 2014

Study information

• Verified date: February 2014
• Source: Karolinska University Hospital
• Contact: Lars Hyllienmark, MD, PhD
• Phone: +46-8-517 729 79
• Email: lars.hyllienmark[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Narcolepsy

Intervention

Device:
• Kinetic Oscillation Stimulation Device

• Kinetic Oscillation Stimulation Device in placebo mode

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scale Epworth Sleep Scale (ESS)	Change in ESS scale between baseline before treatment and at 15-21 days after treatment.	15-21 days	No
Secondary	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.	14 days	No