Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition (NARKOREX)
April 2, 2009 updated by: Zentrum für Integrative Psychiatrie
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kiel, Germany, 24105
- Zentrum für Integrative Psychiatrie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effect of orexine A on sleep, neurocognition and immune-system
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ANTICIPATED)
August 1, 2009
Study Completion (ANTICIPATED)
August 1, 2009
Study Registration Dates
First Submitted
June 8, 2007
First Submitted That Met QC Criteria
June 8, 2007
First Posted (ESTIMATE)
June 11, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
April 3, 2009
Last Update Submitted That Met QC Criteria
April 2, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Narkorex
- DFG-SFB654/C5-Narkorex
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.