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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 22, 2008 | ||||||||
| Last Updated Date | April 23, 2008 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Sleep-EEG variables, conventionally and quantitatively analyzed [ Time Frame: within the first month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00666068 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism | ||||||||
| Official Title ICMJE | Effects of CRH on the Sleep in Patients With Hypopituitarism | ||||||||
| Brief Summary | In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated. It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism. To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacodynamics Study | ||||||||
| Condition ICMJE | Hypopituitarism | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | December 2008 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Patients with hypopituitarism Inclusion Criteria:
Exclusion Criteria:
Healthy controls Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00666068 | ||||||||
| Responsible Party | Prof. Dr. Axel Steiger, Max-Planck-Institute of Psychiatry | ||||||||
| Study ID Numbers ICMJE | L2/2003A | ||||||||
| Study Sponsor ICMJE | Max-Planck-Institute of Psychiatry | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | Max-Planck-Institute of Psychiatry | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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