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Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition (NARKOREX)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Zentrum für Integrative Psychiatrie.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00484757
First Posted: June 11, 2007
Last Update Posted: April 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zentrum für Integrative Psychiatrie
  Purpose
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.

Condition Intervention
Narcolepsy Drug: Orexine A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Zentrum für Integrative Psychiatrie:

Primary Outcome Measures:
  • Effect of orexine A on sleep, neurocognition and immune-system

Study Start Date: June 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484757


Locations
Germany
Zentrum für Integrative Psychiatrie
Kiel, Germany, 24105
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
Investigators
Principal Investigator: Dunja Hinze-Selch, MD Zentrum für Integrative Psychiatrie
  More Information

ClinicalTrials.gov Identifier: NCT00484757     History of Changes
Other Study ID Numbers: Narkorex
DFG-SFB654/C5-Narkorex
First Submitted: June 8, 2007
First Posted: June 11, 2007
Last Update Posted: April 3, 2009
Last Verified: April 2009

Keywords provided by Zentrum für Integrative Psychiatrie:
Narcolepsy
Orexines
sleep
cognition
cytokines

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders