NCT02077036

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

March 4, 2014

Status Verified

February 1, 2014

First QC Date

February 11, 2014

Last Update Submit

February 28, 2014

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in multiple sleep latency test (MSLT)

    14 days

Study Arms (2)

Active medical device

EXPERIMENTAL
Device: Kinetic Oscillation Stimulation Device

Inactive medical device

PLACEBO COMPARATOR
Device: Kinetic Oscillation Stimulation Device in placebo mode

Interventions

Kinetic Oscillation Stimulation DeviceDEVICE
Active medical device
Kinetic Oscillation Stimulation Device in placebo modeDEVICE
Inactive medical device

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Signed informed consent
  • Diagnosed with narcolepsy (diagnose code G47.4)
  • years of age
  • MSLT has shown hypersomnia (sleeping latency \< 8 min) \& 1 episode REM
  • HLA-type associated with increased occurrence of narcolepsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Lars Hyllienmark, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, consultant in neurology and clinical neurophysiology

Study Record Dates

First Submitted

February 11, 2014

First Posted

March 4, 2014

Primary Completion

December 1, 2014

Last Updated

March 4, 2014

Record last verified: 2014-02

Locations

SE(1)