Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Primary Purpose
Hypopituitarism
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
corticotropin releasing hormone (CRH)
Placebo
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Hypopituitarism focused on measuring Patients with hypopituitarism
Eligibility Criteria
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
Sites / Locations
- Max Planck Institute of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Patients with hypopituitarism Cross over design: see interventions 1-2
Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism
Outcomes
Primary Outcome Measures
Sleep-EEG variables, conventionally and quantitatively analyzed
Secondary Outcome Measures
Full Information
NCT ID
NCT00666068
First Posted
April 22, 2008
Last Updated
May 11, 2011
Sponsor
Max-Planck-Institute of Psychiatry
1. Study Identification
Unique Protocol Identification Number
NCT00666068
Brief Title
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Official Title
Effects of CRH on the Sleep in Patients With Hypopituitarism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Max-Planck-Institute of Psychiatry
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopituitarism
Keywords
Patients with hypopituitarism
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with hypopituitarism
Cross over design: see interventions 1-2
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Parallel design:
Healthy controls to be compared with placebo condition in patients with hypopituitarism
Intervention Type
Other
Intervention Name(s)
corticotropin releasing hormone (CRH)
Intervention Description
50 µg injected at 2200, 2300, 0000, and 0100
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
injected at 2200, 2300, 0000, and 0100
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
injected at 2200, 2300, 0000, and 0100
Primary Outcome Measure Information:
Title
Sleep-EEG variables, conventionally and quantitatively analyzed
Time Frame
within the first month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Max Planck Institute of Psychiatry
City
Munich
ZIP/Postal Code
80804
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
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