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

NCT02931474 | Withdrawn Phase 2

• 2 other identifiers: 17000517-NR-0005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Disorder; Traumatic Brain Injury

Keywords

Growth Hormone; Traumatic Brain Injury; Insomnia; Polysomnography; NREM Sleep

Outcome Measures

Primary Outcomes (1)

• Change in NREM time following tesamorelin administration compared to placebo

  1-3 weeks

Secondary Outcomes (1)

• Within and between group differences in plasma concentration levels of neuroendocrine proteins following tesamorelin administration compared to placebo

  1-3 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Salt Water Solution

Other: Placebo

Tesamorelin

EXPERIMENTAL

Growth Hormone-Releasing

Drug: Tesamorelin

Interventions

Tesamorelin DRUG

Growth Hormone-Releasing

Tesamorelin

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• (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

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

MeSH Terms

Conditions

Sleep Wake Disorders; Brain Injuries, Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Jessica Gill, Ph.D.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 13, 2016
• Study Start: October 6, 2016
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: November 19, 2019

Record last verified: 2017-03-08