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

• ClinicalTrials.gov Identifier: NCT00000380
• Recruitment Status: Completed
• First Posted: November 3, 1999
• Last Update Posted: December 3, 2015
• Sponsor: University of Washington
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Michael Vitiello, University of Washington

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).

Condition or disease	Intervention/treatment	Phase
Sleep Disorders	Drug: GHRH	Not Applicable

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: GHRH
Placebo Comparator: Placebo; Placebo	Drug: GHRH

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All

Criteria

Inclusion Criteria:

-

Patients must have:

Age-related sleep impairment.

-

Required:

Estrogen replacement therapy for women.

Contacts and Locations

Sponsors and Collaborators

University of Washington

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Michael Vitiello, PhD; UW

More Information

Publications of Results:

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. 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.

Other Publications:

Merriam GR, Schwartz RS, Vitiello MV. Growth hormone-releasing hormone and growth hormone secretagogues in normal aging. Endocrine. 2003 Oct;22(1):41-8. Review.

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. Review.

• Responsible Party: Michael Vitiello, Professor, Psychiatry and Behavioral Sciences, University of Washington
• ClinicalTrials.gov Identifier: NCT00000380
• Other Study ID Numbers: 10537-A; R01MH053575 ( U.S. NIH Grant/Contract ); DSIR
• First Posted: November 3, 1999
• Last Update Posted: December 3, 2015
• Last Verified: December 2015

Keywords provided by Michael Vitiello, University of Washington:

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:

Sleep Wake Disorders; Parasomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders