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

Disqualifiers: Psychiatric illness, Diabetes, Smoker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

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?

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

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.

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?

Group I: Pituitary Condition Experimental Treatment 5 Interventions

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

Group II: Hypothalamic Condition Experimental Treatment 6 Interventions

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

Group III: Control Condition Experimental Treatment 5 Interventions

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

Group IV: Adrenal/Testis Condition Experimental Treatment 6 Interventions

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

Who Is Running the Clinical Trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lead Sponsor

Trials

105

Recruited

46,600+