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Hormonal Interventions for Sleep Deprivation

Phase 1
Waitlist Available
Led By Peter Liu, MD, PhD
Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men aged 22-45 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Study Summary

This trial will study how two hormone systems are affected by sleep deprivation, as well as the eater's behavior and how it changes when they're sleep deprived.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects from the drugs used might include hormonal imbalances leading to mood changes or fatigue; injection site reactions; allergic responses; headache or dizziness; stomach upset; increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 22 and 45.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Blood Cortisol Concentration
Average Blood Testosterone Concentration
Secondary outcome measures
Caloric Intake
Food Cravings
Hunger Scale
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Pituitary ConditionExperimental Treatment5 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 ConditionExperimental Treatment6 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 ConditionExperimental Treatment5 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 ConditionExperimental Treatment6 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral capsule
2010
Completed Phase 4
~2380
Saline Solution
2016
Completed Phase 4
~5260
Saline Solution for Injection
2011
Completed Phase 4
~630
Dexamethasone Injection
2016
Completed Phase 4
~60
Ganirelix
2013
Completed Phase 4
~4290
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
101 Previous Clinical Trials
46,221 Total Patients Enrolled
Peter Liu, MD, PhDPrincipal InvestigatorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Corticorelin Clinical Trial Eligibility Overview. Trial Name: NCT03142893 — Phase 1
Sleep Deprivation Research Study Groups: Pituitary Condition, Control Condition, Hypothalamic Condition, Adrenal/Testis Condition
Sleep Deprivation Clinical Trial 2023: Corticorelin Highlights & Side Effects. Trial Name: NCT03142893 — Phase 1
Corticorelin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03142893 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Hormonal Mechanisms of Sleep Restriction - Axis Study
2017. "Hormonal Mechanisms of Sleep Restriction - Axis Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03142893.
All > Sleep Deprivation > Testosterone
~10 spots leftby Apr 2025
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