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Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia

NCT02931474 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-11-19

No results posted yet for this study

Summary

Background:

People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone releasing hormone (GHRH) might improve sleep in service members and veterans who have had a TBI.

Objective:

To see if GHRH can improve sleep in people who have had a TBI.

Eligibility:

Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who have had a TBI in the past 6 months to 10 years.

Design:

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube)

Interview about their mood and alcohol and drug use

Questionnaires about their TBI, mood, and sleep

Participants will have 2 overnight study visits a couple weeks apart. These will include:

Physical exam

Urine sample

Two intravenous catheters placed. Blood samples will be taken throughout the night.

Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the other.

Spending the night in the sleep lab. Their brain waves will be recorded with electrodes placed on the scalp.

A questionnaire in the morning about their sleep

Participants will be called a few days after each overnight visit. They will be asked about how they are feeling and to rate their sleep.

Conditions

Interventions

DRUG

Tesamorelin

Growth Hormone-Releasing

OTHER

Placebo

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    lead NIH

Principal Investigators

  • Jessica Gill, Ph.D. · National Institute of Nursing Research (NINR)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2017-03-08
Completion
2017-03-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931474 on ClinicalTrials.gov