Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Information source: Max-Planck-Institute of Psychiatry
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypopituitarism
Intervention: corticotropin releasing hormone (CRH) (Other); Placebo (Other); Placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Max-Planck-Institute of Psychiatry Overall contact:
Axel Steiger, MD, Phone: +49 8930622, Ext: 236, Email: steiger@mpipsykl.de
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.
Clinical Details
Official title: Effects of CRH on the Sleep in Patients With Hypopituitarism
Study design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Sleep-EEG variables, conventionally and quantitatively analyzed
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Axel Steiger, MD, Phone: +49 8930622, Ext: 236, Email: steiger@mpipsykl.de
Max Planck Institute of Psychiatry, Munich 80804, Germany; Recruiting
Michael Kluge, MD, Phone: +49 89 30622, Ext: 396, Email: kluge@mpipsykl.de
Michael Kluge, MD, Sub-Investigator
Additional Information
Starting date: February 2008
Ending date: December 2008
Last updated: April 23, 2008
|
