Narcolepsy - New Potential Treatment

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02077036

Enrollment

Registered

2014-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2014-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy

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.

Interventions

DEVICEKinetic Oscillation Stimulation Device

DEVICEKinetic Oscillation Stimulation Device in placebo mode

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Sweden

Contacts

Primary ContactLars Hyllienmark, MD, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026