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

Not Applicable

Completed

• Conditions: Hypopituitarism
• Interventions: Other: corticotropin releasing hormone (CRH); Other: Placebo

• Registration Number: NCT00666068
• Lead Sponsor: Max-Planck-Institute of Psychiatry

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 available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	corticotropin releasing hormone (CRH)	Patients with hypopituitarism Cross over design: see interventions 1-2
1	Placebo	Patients with hypopituitarism Cross over design: see interventions 1-2
2	Placebo	Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism

Primary Outcome Measures

Name	Time	Method
Sleep-EEG variables, conventionally and quantitatively analyzed	within the first month

Trial Locations

Locations (1)

Max Planck Institute of Psychiatry; 🇩🇪 Munich, Germany