Hypopituitarism Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Max Planck Institute of Psychiatry | Munich |
Lead Sponsor | Collaborator |
---|---|
Max-Planck-Institute of Psychiatry |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep-EEG variables, conventionally and quantitatively analyzed | within the first month | No |
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