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Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances

Primary Purpose

Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GHRH
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: - Patients must have: Age-related sleep impairment. - Required: Estrogen replacement therapy for women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    GHRH

    Placebo

    Arm Description

    Growth-hormone-releasing hormone (GHRH), also known as growth-hormone-releasing factor (GRF, GHRF), somatoliberin or somatocrinin, is a releasing hormone for growth hormone.

    Placebo

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    December 1, 2015
    Sponsor
    University of Washington
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000380
    Brief Title
    Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
    Official Title
    Age-Related Sleep Impairment - Treatment w/GHRH
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1996 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    5. Study Description

    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 he/she 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Disorders
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    GHRH
    Arm Type
    Experimental
    Arm Description
    Growth-hormone-releasing hormone (GHRH), also known as growth-hormone-releasing factor (GRF, GHRF), somatoliberin or somatocrinin, is a releasing hormone for growth hormone.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    GHRH

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: - Patients must have: Age-related sleep impairment. - Required: Estrogen replacement therapy for women.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Vitiello, PhD
    Organizational Affiliation
    UW
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14610297
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9449031
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16399214
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    15172206
    Citation
    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.
    Results Reference
    result

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