Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00000380
First received: November 2, 1999
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT).

Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women.

40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo.

An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).


Condition Intervention
Sleep Disorders
Drug: GHRH

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Age-Related Sleep Impairment - Treatment w/GHRH

Resource links provided by NLM:


Further study details as provided by University of Washington:

Study Start Date: June 1996
Estimated Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GHRH
Growth-hormone-releasing hormone (GHRH), also known as growth-hormone-releasing factor (GRF, GHRF), somatoliberin or somatocrinin, is a releasing hormone for growth hormone.
Drug: GHRH
Placebo Comparator: Placebo
Placebo

Detailed Description:

To examine the effects of synthetic growth hormone releasing hormone (GHRH) versus placebo on the sleep quality, 24-hour secretory pattern of growth hormone (GH), and insulin-like growth factor 1 (IGF-1) concentrations of 40 healthy older men and 40 healthy older women on estrogen replacement therapy (ERT). To determine if augmenting the GH-IGF-1 axis can improve the objective sleep quality of the older population. To determine if treatment-related changes in sleep quality are correlated with changes in GH and/or IGF-1 concentrations.

Nearly 40% of the geriatric population complain of poor sleep quality, a complaint that is validated by objective findings. The physiological consequences of age-impaired sleep are poorly understood, but may include damped circadian rhythms and impaired anabolic hormone status. Poor sleep may also account for the disproportionate prescription of sedative hypnotics to older adults which may exacerbate sleep apnea, lead to daytime carryover effects such as sedation, falls, fractures, cognitive impairment, and anterograde amnesia, and has been associated with increased morbidity and mortality. The recent NIH Consensus Conference on the Treatment of Sleep Disorders in Older People concluded that nonsedative interventions to improve sleep quality in the elderly population are obviously needed. One such intervention may be stimulation of the GH-IGF-1 axis by GHRH administration. Clinical evidence indicates sleep quality can be affected by extremes of GH status and several recent studies report acute GHRH administration improves sleep quality in young men. We have recently demonstrated that measures of sleep quality correlate with basal IGF-1 concentrations in healthy older men and ERT women.

40 healthy older men and 40 healthy older women on ERT receive either GHRH or placebo.

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

-

Patients must have:

Age-related sleep impairment.

-

Required:

Estrogen replacement therapy for women.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000380

Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Michael Vitiello, PhD UW
  More Information

Publications:
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00000380     History of Changes
Other Study ID Numbers: MH53575, R01MH053575, DSIR
Study First Received: November 2, 1999
Last Updated: August 1, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Adult
Estrogen Replacement Therapy
Female
Hormone Replacement Therapy
Human
Insulin-Like Growth Factor I
Male
Placebos
Sleep Disorders
Somatotropin-Releasing Hormone
Somatotropin
Insulin-Like Growth Factor I -- secretion
Sleep Disorders -- *drug therapy
Somatotropin-Releasing Hormone -- *therapeutic use
Somatotropin -- secretion

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014