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.
Will I have to stop taking my current medications?
The trial excludes participants who are currently on medical or drug treatment, so you would need to stop taking your current medications to participate.
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
Trial Overview
The study is examining how lack of sleep affects two hormone systems in the body (HPA axis and HPG axis) by using various medications including Dexamethasone, Hydrocortisone, Gonadorelin and others versus placebo to see their impact on stress response, reproductive hormones and cognitive functions related to food intake.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
8am - Saline Solution for Injection 10am - Ketoconazole Pill 1pm - Saline Solution for Injection 4pm - Ketoconazole Pill \& start of hourly blood sampling 7pm - GnRH and CRH 9pm - Hydrocortisone Injection \& last blood sample
8 am - Ganirelix 10 am - Placebo oral capsule 1 pm - Dexamethasone injection 4 pm - Placebo oral capsule and start of hourly blood sampling 7 pm - GnRH and CRH injections 9 pm - Saline Solution for Injection and last sample of blood taken
8 am - Saline Solution for Injection 10 am - Placebo oral capsule 1 pm - Saline Solution for Injection 4 pm - Placebo oral capsule \& start hourly blood sampling 7 pm - Gonadorelin (GnRH) and Corticorelin (CRH) injections 9 pm - Saline Solution for Injection \& last blood sample
10pm - Ganirelix Injection \& Dexamethasone Pills (night before) 8am - start of hourly blood sampling 10am - Dexamethasone Pills 11am - last hourly blood sample taken 11:30am - start of blood sampling every 10 minutes 1pm - Recombinant Human Luteinizing Hormone (rhLH) Injection 3pm - rhLH Injection 5pm - rhLH Injection 5pm - Cosyntropin Injectable product 7pm - GnRH and CRH Injections 9pm - last blood sample taken
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
Citations
Mechanisms of Dexamethasone-Induced Disturbed Sleep ...
Even at baseline OFF DEX, patients had poor sleep quality with significantly poorer average sleep efficiency average of 84% (sleep efficiency = time asleep/ ...
Dexamethasone induces sleep disturbance in a dose ...
Our results revealed that DXM increased the time spent in arousal and decreased that of NREM sleep, even at very low doses. These results imply ...
Sleep deprivation and hypothalamic-pituitary-adrenal (HPA ...
Data from partial sleep deprivation (PSD) studies indicated that PSD in the second half of the night is therapeutically superior to PSD in the first half of the ...
Unraveling Dexamethasone-Induced Neurobehavioral and ...
Furthermore, parents who experienced more stress before start of a dexamethasone course reported more sleep problems in their child (OR, 1.16; ...
Sleep deprivation predisposes allergic mice to neutrophilic ...
Collectively, our data show that sleep quality participates in the progression of allergen-induced eosinophilic lung inflammation to corticosteroid-refractory ...
Effects of Insufficient Sleep on Pituitary–Adrenocortical ...
Severe sleep restriction results in elevated evening cortisol levels. We examined whether this relative hypercortisolism is associated with alterations in ...
Influence of Sleep Deprivation and Circadian Misalignment on ...
Sleep deprivation can also lead to increased CRH and subsequent corticosterone levels (e.g., Opp 1995). The individual participant cortisol data showing peaks ...
Corticotropin-releasing hormone modulates NREM sleep ...
These data suggest that boosting CRH release in the TRN reduces sleep spindle density and induces fragmented sleep, as indicated by ...
Central Deficiency of Corticotropin-Releasing Hormone ...
The results demonstrated that i.c.v. injected CRH immediately promotes wakefulness and in turn suppresses sleep, namely both NREMS and REMS, in C57BL/6J mice.
Sleep and the hypothalamo–pituitary–adrenocortical system
The intention of this review is to summarize the current knowledge on the bidirectional interaction between sleep EEG and the secretion of corticotropin ...
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