Narcolepsy - New Potential Treatment | NCT02077036

Studies
Narcolepsy - New Potential Treatment

NCT02077036

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

Mar 4, 2014Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Narcolepsy

Interventions

Kinetic Oscillation Stimulation Device
Kinetic Oscillation Stimulation Device in placebo mode

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Feb 11, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lars Hyllienmark, Associate professor, consultant in neurology and clinical neurophysiology, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active medical device	Experimental		Device: Kinetic Oscillation Stimulation Device
Inactive medical device	Placebo Comparator		Device: Kinetic Oscillation Stimulation Device in placebo mode

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kinetic Oscillation Stimulation Device	Device		Active medical device
Kinetic Oscillation Stimulation Device in placebo mode

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lars Hyllienmark, MD, PhD	Contact	+46-8-517 729 79		lars.hyllienmark@karolinska.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital	Recruiting	Stockholm			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D009290	Narcolepsy

Ancestor Terms

ID	Term
D006970	Disorders of Excessive Somnolence
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided