Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
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|ClinicalTrials.gov Identifier: NCT02931474|
Recruitment Status : Withdrawn
First Posted : October 13, 2016
Last Update Posted : November 19, 2019
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.
To see if GHRH can improve sleep in people who have had a TBI.
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.
Participants will be screened with:
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:
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorder Traumatic Brain Injury||Drug: Tesamorelin Other: Placebo||Phase 2|
Objective: Traumatic brain injury (TBI) is the hallmark injury of deployment in Iraq and Afghanistan. Up to one-third of service members who sustain a TBI are diagnosed with a sleep disorder; insomnia being one of the most common. Currently, over half of TBI-associated insomnia cases remain untreated due to poor efficacy of available pharmacologic agents. Neuroendocrine dysfunction is an important mechanism linking TBI and disordered sleep, thus pharmacological agents that address this dysfunction may be effective in treating TBI-related insomnia. The neuroendocrine system is essential for regulating sleep and circadian function. Decreased neuroendocrine function, including the hypothalamus and the somatotrophic cells of the anterior pituitary, which regulate growth hormone secretion, likely contributes to insomnia. This assertion is supported by previous studies that demonstrated the sleep-promoting effects of growth hormone releasing hormone (GHRH) administration in healthy controls, the elderly, and participants with depression. Therefore, we propose that administration of GHRH will address the underlying mechanisms of insomnia in service members and veterans who sustained a TBI, and provide a pharmacological agent more robust than currently available treatments.
Study population: This study will recruit 50 active duty service members and veterans with a documented TBI to participate in one of two study groups. The insomnia group (n=25) will include participants that have a current clinical diagnosis of insomnia without obstructive sleep apnea. The no-insomnia group (n=25) will include participants with no current clinical diagnosis of insomnia or obstructive sleep apnea. Withdrawals/dropouts will be replaced to obtain 20 participants per group who complete the study.
Design: A double-blind, randomized, crossover design will be used to examine the impact of tesamorelin (GHRH (1-44) analog) or placebo on total non-rapid eye movement (NREM) time evaluated during two polysomnography visits, scheduled 1-3 weeks apart. Serial blood draws will be obtained during the polysomnography to examine endocrine function and neuropeptide release.
Outcome measures: The primary outcome is change in NREM time following tesamorelin administration compared to placebo. The secondary outcomes are (1) within and between group differences in plasma concentration levels of neuroendocrine proteins following tesamorelin administration compared to placebo and (2) within and between group differences in urinary concentration levels of growth hormone following tesamorelin administration compared to placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia|
|Study Start Date :||October 6, 2016|
|Actual Primary Completion Date :||March 8, 2017|
|Actual Study Completion Date :||March 8, 2017|
Placebo Comparator: Placebo
Salt Water Solution
- Change in NREM time following tesamorelin administration compared to placebo [ Time Frame: 1-3 weeks ]
- Within and between group differences in plasma concentration levels of neuroendocrine proteins following tesamorelin administration compared to placebo [ Time Frame: 1-3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931474
|Principal Investigator:||Jessica Gill, Ph.D.||National Institute of Nursing Research (NINR)|