Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition (NARKOREX)
Primary Purpose
Narcolepsy
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Orexine A
Sponsored by
About this trial
This is an interventional basic science trial for Narcolepsy focused on measuring Narcolepsy, Orexines, sleep, cognition, cytokines
Eligibility Criteria
Inclusion Criteria:
- Narcolepsy
- Age >18
- Informed consent
- GERMAN fluently spoken
Exclusion Criteria:
- Additional severe psychiatric or somatic disorders
- Pregnancy or nursing
- Anemia (Hb<10g/dl)
Sites / Locations
- Zentrum für Integrative Psychiatrie
Outcomes
Primary Outcome Measures
Effect of orexine A on sleep, neurocognition and immune-system
Secondary Outcome Measures
Full Information
NCT ID
NCT00484757
First Posted
June 8, 2007
Last Updated
April 2, 2009
Sponsor
Zentrum für Integrative Psychiatrie
1. Study Identification
Unique Protocol Identification Number
NCT00484757
Brief Title
Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition
Acronym
NARKOREX
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Zentrum für Integrative Psychiatrie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy
Keywords
Narcolepsy, Orexines, sleep, cognition, cytokines
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Orexine A
Primary Outcome Measure Information:
Title
Effect of orexine A on sleep, neurocognition and immune-system
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Narcolepsy
Age >18
Informed consent
GERMAN fluently spoken
Exclusion Criteria:
Additional severe psychiatric or somatic disorders
Pregnancy or nursing
Anemia (Hb<10g/dl)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dunja Hinze-Selch, MD
Organizational Affiliation
Zentrum für Integrative Psychiatrie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Integrative Psychiatrie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition
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