Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
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| ClinicalTrials.gov Identifier: NCT00000380 |
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Recruitment Status :
Completed
First Posted : November 3, 1999
Last Update Posted : December 3, 2015
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Disorders | Drug: GHRH | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | Age-Related Sleep Impairment - Treatment w/GHRH |
| Study Start Date : | June 1996 |
| Actual Primary Completion Date : | July 2007 |
| Study Completion Date : | July 2007 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: GHRH |
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Placebo Comparator: Placebo
Placebo
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Drug: GHRH |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
Inclusion Criteria:
Patients must have:
Age-related sleep impairment.
Required:
Estrogen replacement therapy for women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000380
| Principal Investigator: | Michael Vitiello, PhD | UW |
Publications of Results:
Other Publications:
| Responsible Party: | Michael Vitiello, Professor, Psychiatry and Behavioral Sciences, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00000380 History of Changes |
| Other Study ID Numbers: |
10537-A R01MH053575 ( U.S. NIH Grant/Contract ) DSIR |
| First Posted: | November 3, 1999 Key Record Dates |
| Last Update Posted: | December 3, 2015 |
| Last Verified: | December 2015 |
Keywords provided by Michael Vitiello, University of Washington:
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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:
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Sleep Wake 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 |