Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000380
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
1999-11-02
Brief Title:
Growth Hormone Releasing Hormone GHRH Treatment for Age-Related Sleep Disturbances
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Age-Related Sleep Impairment - Treatment wGHRH
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 heshe is a healthy older man or woman with sleep disturbances and is on estrogen replacement therapy women
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 heshe is a healthy older man or woman with sleep disturbances and is on estrogen replacement therapy women
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH053575 |
| R01MH053575 | NIH | None | None |