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Trial NCT00000380

Resource URI: http://static.linkedct.org/resource/trials/NCT00000380
linkedct:brief_title Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
linkedct:condition <http://static.linkedct.org/resource/condition/12180>
linkedct:criteria Inclusion Criteria: - Patients must have: Age-related sleep impairment. - Required: Estrogen replacement therapy for women.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000380
rdfs:label Trial NCT00000380
linkedct:lastchanged_date July 26, 2007
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:nct_id NCT00000380
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Age-Related Sleep Impairment - Treatment w/GHRH
linkedct:org_study_id MH53575
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/41387>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000380>
linkedct:phase N/A
linkedct:reference <http://static.linkedct.org/resource/reference/19935>
linkedct:reference <http://static.linkedct.org/resource/reference/53717>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/3870>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/5528>
linkedct:secondary_id DSIR
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date June 1996
linkedct:study_design Treatment, Placebo Control
linkedct:study_type Interventional
linkedct:summary 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).
rdf:type linkedct:trials
linkedct:verification_date July 2007