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Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism

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.
 
ClinicalTrials.gov Identifier: NCT00666068
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : May 12, 2011
Sponsor:
Information provided by:
Max-Planck-Institute of Psychiatry

Tracking Information
First Submitted Date  ICMJE April 22, 2008
First Posted Date  ICMJE April 24, 2008
Last Update Posted Date May 12, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
Sleep-EEG variables, conventionally and quantitatively analyzed [ Time Frame: within the first month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Hypopituitarism
Intervention  ICMJE
  • Other: corticotropin releasing hormone (CRH)
    50 µg injected at 2200, 2300, 0000, and 0100
  • Other: Placebo
    injected at 2200, 2300, 0000, and 0100
Study Arms  ICMJE
  • Experimental: 1

    Patients with hypopituitarism

    Cross over design: see interventions 1-2

    Interventions:
    • Other: corticotropin releasing hormone (CRH)
    • Other: Placebo
  • Placebo Comparator: 2

    Parallel design:

    Healthy controls to be compared with placebo condition in patients with hypopituitarism

    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 23, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Patients with hypopituitarism

Inclusion Criteria:

  • Age 18-75 years
  • Complete insufficiency of the anterior pituitary
  • Stable hormone substitution for at least 3 months

Exclusion Criteria:

  • Hormone excess in the past
  • Sleep disorder, e.g. sleep apnea syndrome

Healthy controls

Inclusion Criteria:

  • Age 18-75 years

Exclusion Criteria:

  • Any medication during 6 week prior to study entry
  • Shift work
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00666068
Other Study ID Numbers  ICMJE L2/2003A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Axel Steiger, Max-Planck-Institute of Psychiatry
Study Sponsor  ICMJE Max-Planck-Institute of Psychiatry
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Max-Planck-Institute of Psychiatry
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP