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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

November 2, 1999
August 1, 2012
June 1996
July 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000380 on ClinicalTrials.gov Archive Site
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Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
Age-Related Sleep Impairment - Treatment w/GHRH

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).

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.

Interventional
Not Provided
Primary Purpose: Treatment
Sleep Disorders
Drug: GHRH
  • 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.
    Intervention: Drug: GHRH
  • Placebo Comparator: Placebo
    Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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Patients must have:

Age-related sleep impairment.

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Required:

Estrogen replacement therapy for women.

Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00000380
MH53575, R01MH053575, DSIR
Not Provided
University of Washington
University of Washington
National Institute of Mental Health (NIMH)
Principal Investigator: Michael Vitiello, PhD UW
University of Washington
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP