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

December 1, 2015 updated by: Michael Vitiello, University of Washington

Age-Related Sleep Impairment - Treatment w/GHRH

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Patients must have:

Age-related sleep impairment.

-

Required:

Estrogen replacement therapy for women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: GHRH
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michael Vitiello, PhD, UW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Primary Completion (ACTUAL)

July 1, 2007

Study Completion

July 1, 2007

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (ESTIMATE)

November 3, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10537-A
  • DSIR
  • R01MH053575 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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