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

NCT00000380 | Completed

• 3 other identifiers: 10537-AR01MH053575DSIR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Study Arms (2)

GHRH

EXPERIMENTAL

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

PLACEBO COMPARATOR

Placebo

Drug: GHRH

Interventions

GHRH DRUG

GHRH; Placebo

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (4)

• 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.

  PMID: 14610297 BACKGROUND

• 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.

  PMID: 9449031 BACKGROUND

• 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.

  PMID: 16399214 RESULT

• 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.

  PMID: 15172206 RESULT

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Michael Vitiello, PhD

  UW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: June 1, 1996
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 3, 2015

Record last verified: 2015-12