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

Max-Planck-Institute of Psychiatry

Status: Completed

Conditions: Hypopituitarism

Treatments: Other: Placebo; Other: corticotropin releasing hormone (CRH)

Study type: Interventional

Funder types: Other

Identifiers

NCT00666068

L2/2003A

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Patients with hypopituitarism Cross over design: see interventions 1-2

Treatment:

Other: Placebo

Other: corticotropin releasing hormone (CRH)

Other: Placebo

2

Placebo Comparator group

Description:

Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism

Treatment:

Other: Placebo

Other: Placebo