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Corticosteroid

Hormonal Treatments 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 or postmenopausal women aged 60-80 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Study Summary

This trial looks at how the body responds to sleep deprivation and restricted sleep, and how this affects thinking and decision-making around food.

Who is the study for?
This trial is for healthy men or postmenopausal women aged 60-80 with a stable weight, BMI of 22-28, good sleep habits, and no extreme morning or evening preferences. Excluded are those on medication, with vision/hearing impairments not corrected to normal, anemia, endocrine abnormalities including diabetes, smokers, recent drug/alcohol abuse history, irregular bedtimes or travel across time zones within the last month.Check my eligibility
What is being tested?
The study tests how sleep restriction affects stress (HPA axis) and reproductive hormone (HPG axis) systems in older adults. It involves administering various hormones and drugs like Gonadorelin and Dexamethasone to see their impact on cognitive functions related to restricted sleep such as food intake and cravings.See study design
What are the potential side effects?
Possible side effects from the interventions may include hormonal imbalances due to Gonadorelin or Luveris; immune system changes from Dexamethasone; liver issues from Ketoconazole; allergic reactions to Corticorelin; injection site reactions from Ganirelix or Cosyntropin; and general risks associated with placebo controls.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man or a postmenopausal woman aged between 60 and 80.

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
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Pituitary ConditionExperimental Treatment5 Interventions
8 am - Saline Solution for Injection 10 am - Ketoconazole Pill 1 pm - Saline Solution for Injection 4 pm - Ketoconazole Pill & start of hourly blood sampling 7 pm - GnRH and CRH 9 pm - Hydrocortisone Injection and 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 blood sample
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
10 pm - Ganirelix Injection & Dexamethasone Pills (night before) 8 am - Start of hourly blood sampling 10 am - Dexamethasone Pills 11 am - Last hourly blood sample taken 11:30 am - Start of blood sampling every 10 minutes 1 pm - Recombinant Human Luteinizing Hormone (rhLH) Injection 3 pm - rhLH Injection 5 pm - rhLH Injection 5 pm - Cosyntropin Injectable product 7 pm - GnRH and CRH Injections 9 pm - Last blood sample
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ganirelix
FDA approved
Dexamethasone
FDA approved
Saline Solution
2016
Completed Phase 4
~5260
Placebo oral tablet
2019
Completed Phase 4
~2450

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
101 Previous Clinical Trials
46,296 Total Patients Enrolled
Peter Liu, MD, PhDPrincipal InvestigatorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Corticorelin (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04037605 — Phase < 1
Sleep Deprivation Research Study Groups: Adrenal/Testis Condition, Hypothalamic Condition, Control Condition, Pituitary Condition
Sleep Deprivation Clinical Trial 2023: Corticorelin Highlights & Side Effects. Trial Name: NCT04037605 — Phase < 1
Corticorelin (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04037605 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What discoveries have been made regarding the use of Dexamethasone Pill in prior investigations?

"Presently, 173 Phase 3 Dexamethasone Pill trials are active with a total of 662 studies being conducted. The majority of these medical experiments take place in Elk Grove Village, Illinois; however, there are 21,619 other sites that have launched clinical trials for this drug."

Answered by AI

What is Dexamethasone Pill typically administered for?

"Dexamethasone Pill is ordinarily prescribed to treat ocular conditions. Nevertheless, it may also be utilized for ulcerative colitis, acute retinal necrosis due to varicella-zoster virus and anterior pituitary analyses."

Answered by AI

Are there vacancies for enrolment in this clinical trial?

"The information on clinicaltrials.gov indicates that this particular trial is no longer open to recruitment, having first been posted 2/9/2020 and last updated 10/25/2022. Nevertheless, 669 other studies have opened up their participants search process at the same time."

Answered by AI

What objectives is this clinical trial hoping to accomplish?

"This clinical trial will assess the average blood testosterone concentration of its participants over a course of 5 days and use this as their primary outcome. As secondary outcomes, they are assessing how 4 nights of sleep restriction affects decision making with their Two Card Gambling Task by measuring discriminability index d', reaction time on Psychomotor Vigilance Task (measured in lapses), and hunger levels using Flint Visual Analogue Scale's 8-scale rating system."

Answered by AI

Is it feasible for individuals under the age of 30 to participate in this experiment?

"This investigation is admitting individuals aged between 60 and 80 years."

Answered by AI

How many experimentees have been recruited thus far for this research?

"This clinical trial has since closed, as the last update was on October 25th 2022. If you are interested in alternative studies, there are currently 7 trials seeking participants for sleep restriction and 662 studies recruiting patients to take Dexamethasone pills."

Answered by AI

Am I eligible to join this research endeavor?

"This trial seeks to enlist 5 people aged between 60 and 80 who have difficulty obtaining adequate rest. The following conditions must also be met: male gender or postmenopausal status, BMI of 22-28 kg/m2, average morningness-eveningness personality type, general physical healthiness and psychological stability, regular sleep patterns with consistent bedtimes over the last 6 weeks, no drastic changes in weight in recent times."

Answered by AI
~1 spots leftby Apr 2025