Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02931474
Status:
WITHDRAWN
Last Update Posted:
2019-11-19
First Post:
2016-10-12
Brief Title:
Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2017-03-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 n25 will include participants that have a current clinical diagnosis of insomnia without obstructive sleep apnea The no-insomnia group n25 will include participants with no current clinical diagnosis of insomnia or obstructive sleep apnea Withdrawalsdropouts 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 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 n25 will include participants that have a current clinical diagnosis of insomnia without obstructive sleep apnea The no-insomnia group n25 will include participants with no current clinical diagnosis of insomnia or obstructive sleep apnea Withdrawalsdropouts 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-NR-0005 | None | None | None |