Hormonal Interventions for Sleep Deprivation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different hormones affect sleep deprivation and its impact on thinking skills and food cravings. Researchers test various treatments, including injections and pills, to see their influence on hormones related to stress and reproduction. Treatments under study include Corticorelin, Dexamethasone (also known as Decadron, Dexone, or Hexadrol), Ganirelix, Gonadorelin, Hydrocortisone Injection, and a placebo oral capsule. Men with stable weight, non-smokers, and those maintaining regular sleep schedules might be suitable candidates for this study. The goal is to better understand how sleep loss affects the body and mind, potentially leading to improved treatments for sleep-related issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive these innovative treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments tested in this trial have different safety profiles.
Corticorelin may alter sleep patterns, leading to poorer sleep quality. It can increase cortisol, a stress hormone, during sleep deprivation, potentially causing disrupted sleep.
Dexamethasone, a type of steroid, affects sleep and can cause issues like insomnia (difficulty sleeping) and hypersomnia (excessive sleepiness), depending on the dose.
Ganirelix has generally been well-tolerated in previous studies, but it might impact fertility or cause problems with organs like the liver or adrenal glands.
Gonadorelin, used to manage hormones related to reproduction, hasn't shown major safety concerns in sleep studies. However, it can influence the release of hormones like LH and FSH, which are important for reproduction.
Hydrocortisone, another steroid, may cause sleep issues similar to other steroids. It can also increase appetite and lead to weight gain, among other effects.
These drugs are in an early trial phase, so researchers are closely monitoring their safety. Participants should consider possible side effects and discuss them with their healthcare providers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for sleep deprivation because they explore hormonal interventions that target the body's stress and reproductive hormone systems. Unlike typical treatments focusing on lifestyle changes or medications like melatonin, these approaches involve drugs like Ganirelix and Dexamethasone, which influence how hormones are released and regulated. By using combinations of injections and pills to manipulate hormone levels, these treatments aim to provide new insights into how hormonal balance affects sleep patterns, potentially offering quicker or more effective relief for those struggling with sleep issues. This trial could uncover novel ways to reset the body's internal clock and improve sleep quality by targeting the underlying hormonal imbalances.
What evidence suggests that this trial's treatments could be effective for sleep deprivation?
This trial will explore various hormonal interventions for sleep deprivation. Research has shown that dexamethasone, which participants in the Adrenal/Testis Condition arm may receive, can affect sleep by increasing alertness and reducing deep sleep, even in small amounts. This suggests it might not directly address sleep loss but could alter sleep patterns in other ways. In the Hypothalamic Condition arm, participants will receive a combination of dexamethasone and ganirelix, targeting hormones that control sleep cycles. This combination may help researchers understand how these hormones affect sleep and cognition. While no clear evidence yet supports its effectiveness for sleep loss, understanding these processes could lead to better treatments in the future.678910
Who Is on the Research Team?
Peter Liu, MD, PhD
Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Are You a Good Fit for This Trial?
Men aged 22-45 with a BMI of 20-28 kg/m2, stable weight for the last six weeks, and no history of significant health issues like brain injury, endocrine abnormalities, diabetes, or drug/alcohol abuse. Participants must not be smokers or have sleep/circadian disorders and should not have traveled across time zones recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Sleep Opportunity
Participants are admitted to the chronobiology laboratory and given 1 night of 10 hours sleep opportunity
Sleep Restriction
Participants undergo 4 nights of 4 hours sleep opportunity with various experimental conditions
Follow-up
Participants are monitored for changes in hormonal levels and cognitive function after sleep restriction
What Are the Treatments Tested in This Trial?
Interventions
- Corticorelin
- Dexamethasone
- Ganirelix
- Gonadorelin
- Hydrocortisone Injection
- Placebo oral capsule
- Saline Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
Peter y. Liu
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Lead Sponsor