Narcolepsy - New Potential Treatment

Karolinska University Hospital

Status

Unknown

Conditions

Narcolepsy

Treatments

Device: Kinetic Oscillation Stimulation Device

Device: Kinetic Oscillation Stimulation Device in placebo mode

Study type

Interventional

Funder types

Other

Identifiers

NCT02077036

nervus11

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

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