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

What Was Tested

In this phase 2 trial, researchers set out to test Tesamorelin.

Background: People who have had a traumatic brain injury (TBI) often have trouble sleeping.

TBI may also alter hormones, which can cause poor sleep.

It had two arms (groups): Placebo (placebo comparator) and Tesamorelin (experimental).

Salt Water Solution.

Growth Hormone-Releasing.

The registry classes the interventions as drug and other.

More on the Plan

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.

The neuroendocrine system is essential for regulating sleep and circadian function.

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.

Who Took Part

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. (For women only) agree not to breastfeed from the time of enrollment in the study until 1 month after the last exposure to tesamorelin.

The full record lists 12 inclusion and 15 exclusion criteria; among the exclusions: have obstructive sleep apnea determined by polysomnography (insomnia group) or selfreport (no-insomnia group); have a known hypersensitivity to tesamorelin and/or mannitol; are under treatment for a major injury (e.g., amputation, burns, eye injury, skeletal injury, severe infection, etc.).

How the Study Was Run

Design: randomized, crossover and triple-blind.

The participants were allocated by chance, so the Tesamorelin group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Tesamorelin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Tesamorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-10-06 with completion listed for 2017-03-08.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in NREM time following tesamorelin administration compared to placebo (time frame: 1-3 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tesamorelin compound page, all human trials.