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NCT Number: NCT00666068

Effects of Corticotropin Releasing Hormone (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.

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Key information

Conditions

Hypopituitarism Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max Planck Institute of Psychiatry

Munich, 80804, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

corticotropin releasing hormone (CRH)

Other

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

Placebo

Other

injected at 2200, 2300, 0000, and 0100

Primary outcomes

  1. Sleep-EEG variables, conventionally and quantitatively analyzed

    Time frame: within the first month

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Registry information

Official study title

Effects of CRH on the Sleep in Patients With Hypopituitarism

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 24, 2008
Registry last updated
May 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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