Skip to content

Trial · Interventional

WithdrawnPhase 2Registry data

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

NCTNCT02931474 (opens ClinicalTrials.gov in a new tab)Other id170005Other id17-NR-0005

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
National Institute of Nursing Research (NINR) · Nih
Design
Randomized · Triple masking
Countries
Not stated
Start
6 Oct 2016
Primary completion
8 Mar 2017
Completion
8 Mar 2017
First posted
13 Oct 2016 (estimated)
Last update posted
19 Nov 2019
Conditions
Sleep Disorder · Traumatic Brain Injury

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

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

    NCT02931474

    6 Oct 2016 to 8 Mar 2017

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TesamorelinDrug
  • PlaceboOther

Arms2

  • Placebo comparator

    Placebo

    Salt Water Solution

  • Experimental

    Tesamorelin

    Growth Hormone-Releasing

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in NREM time following tesamorelin administration compared to placebo

    Time frame · 1-3 weeks

Secondary outcomes(1)
  1. Within and between group differences in plasma concentration levels of neuroendocrine proteins following tesamorelin administration compared to placebo

    Time frame · 1-3 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA: Both groups may be eligible for this research study if they: 1. Are between 18 and 45 years of age (on Visit 1) 2. Are active duty service members or veterans who were active duty within the past 10 years (on Visit 1) 3. Are able to provide medical records documenting a TBI, which occurred within the past 6 months to 10 years (on Visit 1) 4. Are able to provide their own consent 5. Are able to understand the study, as shown by scoring a 6 out of 6 on a consent quiz 6. (For women only) agree not to breastfeed from the time of enrollment in the study until 1 month after the last exposure to tesamorelin 7. (For women of childbearing potential only) have a negative urine pregnancy test and agree to use two effective methods of contraception from the time of enrollment in the study until 1 month after the last exposure to tesamorelin The insomnia group may be eligible for this research study if they: 1. Have a current clinical diagnosis of insomnia determined by polysomnography 2. Have a PSQI score greater than 10 The no-insomnia group may be eligible for this research study if they: 1. Have no current clinical diagnosis of insomnia determined by self-report 2. Have a PSQI score less than or equal to 5 EXCLUSION CRITERIA: Both groups may not be eligible for this research study if they: 1. Have obstructive sleep apnea determined by polysomnography (insomnia group) or selfreport (no-insomnia group) 2. Have a known hypersensitivity to tesamorelin and/or mannitol 3. Have taken any of the following medications within the past 30 days: benzodiazepines (e.g., Valium, Ativan, etc.); benzodiazepine receptor agonists (e.g., Ambien, Lunesta, etc.); opiates (e.g., Codeine, Percocet, etc.); or sedatives (e.g., Amytal, Numbutal, etc.) 4. Cannot abstain from using stimulants such as amphetamines (e.g., Adderall, Ritalin, etc.); caffeine (e.g., coffee, cola, etc.); ephedrine (e.g., diet pills, energy drinks, etc.); and eugeroics (e.g., Modafinil, Provigil, etc.) from at least 9:00 AM on Visits 2 and 3 5. Are under treatment for a major injury (e.g., amputation, burns, eye injury, skeletal injury, severe infection, etc.) 6. Have a major medical illness (e.g., active malignancy, cardiovascular disease, diabetes mellitus, HIV, etc.) 7. Are at risk for self-harm determined by a licensed independent practitioner 8. Have indications of recreational substance use determined by a urine drug test 9. Have an abnormal lab value that may indicate major medical illness, which was not cleared by a licensed independent practitioner 10. Have an abnormal lab value that may indicate endocrine dysfunction, which was not cleared by a licensed independent practitioner 11. Have adrenal insufficiency determined by the ACTH stimulation test 12. Have a current bipolar disorder determined by the SCID-IV-TR 13. Have a current psychotic disorder determined by the SCID-IV-TR 14. Have current alcohol dependence determined by the SCID-IV-TR 15. Have current drug dependence determined by the SCID-IV-TR

PepBank is a research reference. Talk to a doctor before you use any peptide.