- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00666068
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Effects of CRH on the Sleep in Patients With Hypopituitarism
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Munich, Germany, 80804
- Max Planck Institute of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Patients with hypopituitarism Cross over design: see interventions 1-2 |
50 µg injected at 2200, 2300, 0000, and 0100
injected at 2200, 2300, 0000, and 0100
|
Placebo Comparator: 2
Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism |
injected at 2200, 2300, 0000, and 0100
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sleep-EEG variables, conventionally and quantitatively analyzed
Time Frame: within the first month
|
within the first month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Hypothalamic Diseases
- Pituitary Diseases
- Hypopituitarism
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
- Adrenocorticotropic Hormone
- Corticotropin-Releasing Hormone
Other Study ID Numbers
- L2/2003A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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