80 Participants Needed

Hormonal Interventions for Sleep Deprivation

Age: 18 - 65
Sex: Male
Trial Phase: Phase 1
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

Who Is on the Research Team?

PL

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

Willingness to provide written informed consent
I am a man aged between 22 and 45.
Body Mass index (BMI) 20-28 kg/m2
See 1 more

Exclusion Criteria

Blood donation in previous eight weeks
I have not traveled across time zones in the last month.
I have issues with my urinary system, but no confirmed prostate cancer.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Sleep Opportunity

Participants are admitted to the chronobiology laboratory and given 1 night of 10 hours sleep opportunity

1 day

Sleep Restriction

Participants undergo 4 nights of 4 hours sleep opportunity with various experimental conditions

4 days

Follow-up

Participants are monitored for changes in hormonal levels and cognitive function after sleep restriction

5 days

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?
4Treatment groups
Experimental Treatment
Group I: Pituitary ConditionExperimental Treatment5 Interventions
Group II: Hypothalamic ConditionExperimental Treatment6 Interventions
Group III: Control ConditionExperimental Treatment5 Interventions
Group IV: Adrenal/Testis ConditionExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lead Sponsor

Trials
105
Recruited
46,600+
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