Trial · Interventional
WithdrawnPhase 2Registry dataImpact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
This trial was withdrawn before it enrolled anyone.
The registry gives no reason.
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- Withdrawn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
- Ph 2Withdrawn
Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
NCT029314746 Oct 2016 to 8 Mar 2017
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.
Change in NREM time following tesamorelin administration compared to placebo
Time frame · 1-3 weeks
Secondary outcomes(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
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