Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
NCT ID: NCT00000380
Last Updated: 2015-12-03
Study Results
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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COMPLETED
NA
INTERVENTIONAL
1996-06-30
2007-07-31
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Study Groups
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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.
GHRH
Placebo
Placebo
GHRH
Interventions
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GHRH
Eligibility Criteria
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Inclusion Criteria
Patients must have:
Age-related sleep impairment.
\-
Required:
Estrogen replacement therapy for women.
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Responsible Party
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Michael Vitiello
Professor, Psychiatry and Behavioral Sciences
Principal Investigators
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Michael Vitiello, PhD
Role: PRINCIPAL_INVESTIGATOR
UW
References
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Merriam GR, Schwartz RS, Vitiello MV. Growth hormone-releasing hormone and growth hormone secretagogues in normal aging. Endocrine. 2003 Oct;22(1):41-8. doi: 10.1385/ENDO:22:1:41.
Merriam GR, Buchner DM, Prinz PN, Schwartz RS, Vitiello MV. Potential applications of GH secretagogs in the evaluation and treatment of the age-related decline in growth hormone secretion. Endocrine. 1997 Aug;7(1):49-52. doi: 10.1007/BF02778062.
Vitiello MV, Moe KE, Merriam GR, Mazzoni G, Buchner DH, Schwartz RS. Growth hormone releasing hormone improves the cognition of healthy older adults. Neurobiol Aging. 2006 Feb;27(2):318-23. doi: 10.1016/j.neurobiolaging.2005.01.010. Epub 2005 Mar 23.
Vitiello MV, Larsen LH, Moe KE. Age-related sleep change: Gender and estrogen effects on the subjective-objective sleep quality relationships of healthy, noncomplaining older men and women. J Psychosom Res. 2004 May;56(5):503-10. doi: 10.1016/S0022-3999(04)00023-6.
Other Identifiers
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DSIR
Identifier Type: -
Identifier Source: secondary_id
10537-A
Identifier Type: -
Identifier Source: org_study_id