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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
Zentrum für Integrative Psychiatrie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Narcolepsy focused on measuring Narcolepsy, Orexines, sleep, cognition, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 8, 2007
Last Updated
April 2, 2009
Sponsor
Zentrum für Integrative Psychiatrie
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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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