Sleep DisorderPhase 2NCT02931474
Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
A Phase 2 study testing Tesamorelin in people with Sleep Disorder and Traumatic Brain Injury, run by National Institute of Nursing Research (NINR).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Sleep Disorder, Traumatic Brain Injury
- What is being tested?
- Tesamorelin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2016to 8 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both groups may be eligible for this research study if they:
- Are between 18 and 45 years of age (on Visit 1)
- Are active duty service members or veterans who were active duty within the past 10 years (on Visit 1)
- Are able to provide medical records documenting a TBI, which occurred within the past 6 months to 10 years (on Visit 1)
- Are able to provide their own consent
- Are able to understand the study, as shown by scoring a 6 out of 6 on a consent quiz
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- (For women only) agree not to breastfeed from the time of enrollment in the study until 1 month after the last exposure to tesamorelin
- (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:
- Have a current clinical diagnosis of insomnia determined by polysomnography
- Have a PSQI score greater than 10
- The no-insomnia group may be eligible for this research study if they:
- Have no current clinical diagnosis of insomnia determined by self-report
- Have a PSQI score less than or equal to 5
Who cannot join
- Both groups may not be eligible for this research study if they:
- Have obstructive sleep apnea determined by polysomnography (insomnia group) or selfreport (no-insomnia group)
- Have a known hypersensitivity to tesamorelin and/or mannitol
- 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.)
- 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
- Are under treatment for a major injury (e.g., amputation, burns, eye injury, skeletal injury, severe infection, etc.)
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- Have a major medical illness (e.g., active malignancy, cardiovascular disease, diabetes mellitus, HIV, etc.)
- Are at risk for self-harm determined by a licensed independent practitioner
- Have indications of recreational substance use determined by a urine drug test
- Have an abnormal lab value that may indicate major medical illness, which was not cleared by a licensed independent practitioner
- Have an abnormal lab value that may indicate endocrine dysfunction, which was not cleared by a licensed independent practitioner
- Have adrenal insufficiency determined by the ACTH stimulation test
- Have a current bipolar disorder determined by the SCID-IV-TR
- Have a current psychotic disorder determined by the SCID-IV-TR
- Have current alcohol dependence determined by the SCID-IV-TR
- Have current drug dependence determined by the SCID-IV-TR
About this study
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
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.
Read more
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.
Read the 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 (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.
- Conditions
- Sleep Disorder, Traumatic Brain Injury
- Being tested
- Tesamorelin, Placebo
- Keywords
- Growth Hormone, Traumatic Brain Injury, Insomnia, Polysomnography, NREM Sleep
- Medical subject headings
- Sleep Wake Disorders, Brain Injuries, Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesamorelinDrug
Growth Hormone-Releasing
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Salt Water Solution Receives: Other: Placebo |
| Tesamorelin | Experimental | Growth Hormone-Releasing Receives: Drug: Tesamorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NREM time following tesamorelin administration compared to placebo
Measured: 1-3 weeks
Secondary outcomes (1)
Within and between group differences in plasma concentration levels of neuroendocrine proteins following tesamorelin administration compared to placebo
Measured: 1-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start6 Oct 2016
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jessica Gill, Ph.D., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931474
- Sponsor's protocol ID
- 170005
- Other IDs
- 17-NR-0005
- Status last verified
- 8 Mar 2017
- First submitted
- 12 Oct 2016
- Last updated
- 19 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02931474
- Acronym / sponsor ID
- 170005
- Conditions
- Sleep Disorder, Traumatic Brain Injury
- Keywords
- Growth Hormone, Traumatic Brain Injury, Insomnia, Polysomnography, NREM Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 6 Oct 2016
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSalt Water Solution |
| Tesamorelin | Experimental | Drug: TesamorelinGrowth Hormone-Releasing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Are between 18 and 45 years of age (on Visit 1)
- Are active duty service members or veterans who were active duty within the past 10 years (on Visit 1)
- Are able to provide medical records documenting a TBI, which occurred within the past 6 months to 10 years (on Visit 1)
- Are able to provide their own consent
- Are able to understand the study, as shown by scoring a 6 out of 6 on a consent quiz
Key exclusion criteria (16 listed)
- Have obstructive sleep apnea determined by polysomnography (insomnia group) or selfreport (no-insomnia group)
- Have a known hypersensitivity to tesamorelin and/or mannitol
- 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.)
- 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
- Are under treatment for a major injury (e.g., amputation, burns, eye injury, skeletal injury, severe infection, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TesamorelinGrowth Hormone-Releasing | Drug | Tesamorelin |
| Placebo | Other | Placebo |
Primary outcome
Change in NREM time following tesamorelin administration compared to placebo
Time frame: 1-3 weeks
1 secondary outcome
Within and between group differences in plasma concentration levels of neuroendocrine proteins following tesamorelin administration compared to placebo
Time frame: 1-3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Gill, Ph.D. principal investigator
National Institute of Nursing Research (NINR)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesamorelin in people with Sleep Disorder and Traumatic Brain Injury, run by National Institute of Nursing Research (NINR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NREM time following tesamorelin administration compared to placebo (time frame: 1-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.