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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypopituitarism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Patients with hypopituitarism

Cross over design: see interventions 1-2

Group Type EXPERIMENTAL

corticotropin releasing hormone (CRH)

Intervention Type OTHER

50 µg injected at 2200, 2300, 0000, and 0100

Placebo

Intervention Type OTHER

injected at 2200, 2300, 0000, and 0100

2

Parallel design:

Healthy controls to be compared with placebo condition in patients with hypopituitarism

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

injected at 2200, 2300, 0000, and 0100

Interventions

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corticotropin releasing hormone (CRH)

50 µg injected at 2200, 2300, 0000, and 0100

Intervention Type OTHER

Placebo

injected at 2200, 2300, 0000, and 0100

Intervention Type OTHER

Placebo

injected at 2200, 2300, 0000, and 0100

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-75 years
* Complete insufficiency of the anterior pituitary
* Stable hormone substitution for at least 3 months

* Age 18-75 years

Exclusion Criteria

* Hormone excess in the past
* Sleep disorder, e.g. sleep apnea syndrome

Healthy controls

* Any medication during 6 week prior to study entry
* Shift work

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes