Sleep RestrictionEarly Phase 1NCT04037605

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

A Early Phase 1 study testing Ketoconazole Pill (also known as nizoral), Ganirelix and Dexamethasone Pill in people with Sleep Restriction, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction and 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. Read more about this study

Who is it for?: Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Restriction
What is being tested?: Ketoconazole Pill (also known as nizoral), Ganirelix and Dexamethasone Pill
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 9 Feb 2020to 24 Jun 2026
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men or postmenopausal women aged 60-80 years
Willingness to provide written informed consent
Stable weight over preceding 6 weeks
Body Mass index (BMI) 22-28 kg/m2
Physically and psychologically healthy
Good habitual sleep with regular bedtimes
Neither extreme morning- nor extreme evening-type using Horne-Ostberg Morningness-Eveningness criteria

Who cannot join

Medications that interfere with the adrenal or gonadal axis will be excluded
Unable or unwilling to provide IRB (Internal Review Board)-approved informed consent
Clinical disorders and/or illnesses
Current medical or drug treatment, as assessed by questionnaire
History of brain injury or of learning disability
Vision or hearing impairment unless corrected back to normal

Show all 22Show fewer

Anemia (Hct <38%)
History of psychiatric illness
Clinically significant abnormalities in blood and urine, and free of traces of drugs
Other endocrine abnormalities including hypothyroidism or adrenal failure; primary gonadal disease as indicated by serum LH (luteinizing hormone) or FSH (follicle stimulating hormone) concentration >10 or >15 IU/L, respectively, hyperprolactinemia indicated by prolactin >25ug/L
Type 2 Diabetes (HgbA1C)
Current smoker
Recent or concurrent drug or alcohol abuse
Blood donation in previous eight weeks
Travel across time zones within one month of entering the study
Sleep or circadian disorder
Shift work within three months of entering the study
Irregular bedtimes (not between 6 and 10 hours in duration)
Unoperated obstructive uropathy, recurrent prostatitis, indeterminate prostatic nodularity, Hx or Suspicion of cancer of the prostate gland or PSA (prostate-specific antigen) >4ng/ml
Previous adverse reaction to sleep deprivation or any of the drugs to be administered
Concurrent participation in another research study
Mini- mental state examination (MMSE) < 27

Trial locations and contacts

1 site in 1 country.

United States1 site

Los Angeles Biomedical Research Institute
Torrance, California, 90509

Other trials in United States

About this study

Read the detailed description

Sleep restriction and its consequences are major public health problems, especially in older adults. Among the more severe physiological sequelae of sleep restriction is the development of insulin resistance. The mechanisms by which sleep restriction leads to increased insulin resistance are unknown, especially in vulnerable older adults; such research informs development of targeted interventions against the sleep loss/insulin resistance link.

This study will administer drugs to clamp the function of each of these nodes to determine the regulatory changes that have occurred with sleep restriction. Even though the study is randomized order in design, the main comparison is before and after sleep restriction under each of these clamp conditions. Participants are admitted to the chronobiology laboratory where they are given 1 night of 10 hours sleep opportunity, followed by 4 nights of 4 hours sleep opportunity.

Up to 40 participants can be enrolled. However, participants will be allowed an opportunity to be randomized to all 4 conditions so that as few as 10 participants may be required. We anticipate 5 men and 5 women will be enrolled assuming each undergoes all 4 clamp conditions.

Conditions: Sleep Restriction
Being tested: Ketoconazole Pill (also known as nizoral), Ganirelix, Dexamethasone Pill, Dexamethasone injection, Cosyntropin Injectable Product
Keywords: Testosterone, Cortisol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketoconazole Pill (also known as nizoral)Drug
Ketoconazole pill is taken 4 times per inpatient visit
GanirelixDrug
Ganirelix subcutaneous injection is administered twice per inpatient visit
Dexamethasone PillDrug
Dexamethasone pills is taken twice per inpatient visit
Dexamethasone injectionDrug
Dexamethasone IV injection is given twice per inpatient visit
Cosyntropin Injectable ProductDrug
Cosyntropin injection is given twice per inpatient visit
Recombinant Human Luteinizing Hormone (also known as luveris)Drug
Recombinant Human Luteinizing Hormone is given as 6 IV infusion pulses per inpatient visit
Hydrocortisone Injection (also known as solu-cortef)Drug
Hydrocortisone IV push is given twice per inpatient visit
Gonadorelin (also known as Lutrepulse)Drug
Gonadorelin IV injection is given twice per inpatient visit
Corticorelin (also known as Acthrel)Drug
Corticorelin IV injection is given twice per inpatient visit
Placebo oral tabletDrug
Placebo for Ketoconazole are given 4 times per inpatient visit
Saline SolutionDrug
Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per inpatient visit
Saline solution for injectionDrug
Saline Solution (placebo) for ganirelix subcutaneous injection

Study groups in NCT04037605
Study group	Role	What they receive
Control Condition	Experimental	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 Receives: Drug: Gonadorelin (also known as Lutrepulse); Drug: Corticorelin (also known as Acthrel); Drug: Placebo oral tablet; Drug: Saline Solution; Drug: Saline solution for injection
Hypothalamic Condition	Experimental	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 Receives: Drug: Ganirelix; Drug: Dexamethasone injection; Drug: Gonadorelin (also known as Lutrepulse); Drug: Corticorelin (also known as Acthrel); Drug: Placebo oral tablet; Drug: Saline solution for injection
Pituitary Condition	Experimental	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 Receives: Drug: Ketoconazole Pill (also known as nizoral); Drug: Hydrocortisone Injection (also known as solu-cortef); Drug: Gonadorelin (also known as Lutrepulse); Drug: Corticorelin (also known as Acthrel); Drug: Saline Solution
Adrenal/Testis Condition	Experimental	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 Receives: Drug: Ganirelix; Drug: Dexamethasone Pill; Drug: Cosyntropin Injectable Product; Drug: Recombinant Human Luteinizing Hormone (also known as luveris); Drug: Gonadorelin (also known as Lutrepulse); Drug: Corticorelin (also known as Acthrel)

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Blood Cortisol Concentration
Cortisol is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.
Measured: 5 days
Average Blood Testosterone Concentration
Testosterone is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.
Measured: 5 days

Secondary outcomes (11)

Peak Blood Cortisol Concentration
This is the single maximal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Measured: 5 days
Peak Blood Testosterone Concentration
This is the single maximal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Measured: 5 days
Trough Blood Cortisol Concentration
This is the single minimal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Measured: 5 days
Trough Blood Testosterone Concentration
This is the single minimal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Measured: 5 days
Reaction time on Psychomotor Vigilance Task
This is measured by lapses in attention. As the person becomes more sleepy, there are more lapses (reaction time >500 ms), at the beginning and at the end of 4 nights of sleep restriction.
Measured: 5 days
Karolinska Sleepiness Scale
Measures how sleepy participants are using a scale of 1 (extremely alert) through 9. This scale will be used to assess changes in sleepiness throughout the day and through 4 nights of sleep restriction.
Measured: 5 days
Two card gambling task
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects participants' decision making. The end point is discriminability index, d'.
Measured: 5 days
Modified Sternberg working memory test
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects reaction time and accuracy.
Measured: 5 days
Caloric Intake
The food given to participants is weighed. The amount that is not consumed is also weighed. The difference in weight is the amount of calories consumed.
Measured: 5 days
Hunger
Hunger levels are assessed using the Flint visual analogue scale (VAS) to assess how 4 nights of sleep restriction affects participants' appetite.The Flint VAS asks the participant to rate 8 aspects of their hunger level on a scale from 1-5.
Measured: 5 days
Food Cravings
Food cravings are measured using the Food Cravings Index (FCI) scale to assess which food groups each participant has cravings for and how their cravings change during 4 nights of sleep restriction. The participant ranks their craving for 33 food items on a scale from 1-5.
Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 202024 Jun 2026

First posted30 Jul 2019
Study start9 Feb 2020
Primary completion24 Jul 2022
Study completion24 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep RestrictionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Blood is sampled every 10 minutes from 4 pm to 9 pm for future mathematical deconvolution in order to determine hormone pulse characteristics in response to the clamp conditions.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04037605
Sponsor's protocol ID: P31056-01R
Status last verified: Sep 2025
First submitted: 24 Jul 2019
Last updated: 11 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Active, not recruitingEarly Phase 1
Sleep and Inflammatory Resolution Pathway
Inflammatory Response, Inflammation
Active, not recruiting
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Prediabetes
Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Obesity (BMI Equal to or >30), Postmenopausal Symptoms

All Sleep Restriction trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women
ClinicalTrials.gov ID: NCT04037605
Acronym / sponsor ID: P31056-01R
Conditions: Sleep Restriction
Keywords: Testosterone, Cortisol
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 5 participants (actual)
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
Study start: 9 Feb 2020 (actual)
Primary completion: 24 Jul 2022 (actual)
Study completion: 24 Jun 2026 (estimated)
First posted: 30 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
Model description: Blood is sampled every 10 minutes from 4 pm to 9 pm for future mathematical deconvolution in order to determine hormone pulse characteristics in response to the clamp conditions.

Arm	Type	Receives
Control Condition	Experimental	Drug: Gonadorelin (also known as Lutrepulse), Drug: Corticorelin (also known as Acthrel), Drug: Placebo oral tablet, Drug: Saline Solution, Drug: Saline solution for injection8 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
Hypothalamic Condition	Experimental	Drug: Ganirelix, Drug: Dexamethasone injection, Drug: Gonadorelin (also known as Lutrepulse), Drug: Corticorelin (also known as Acthrel), Drug: Placebo oral tablet, Drug: Saline solution for injection8 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
Pituitary Condition	Experimental	Drug: Ketoconazole Pill (also known as nizoral), Drug: Hydrocortisone Injection (also known as solu-cortef), Drug: Gonadorelin (also known as Lutrepulse), Drug: Corticorelin (also known as Acthrel), Drug: Saline Solution8 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
Adrenal/Testis Condition	Experimental	Drug: Ganirelix, Drug: Dexamethasone Pill, Drug: Cosyntropin Injectable Product, Drug: Recombinant Human Luteinizing Hormone (also known as luveris), Drug: Gonadorelin (also known as Lutrepulse), Drug: Corticorelin (also known as Acthrel)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

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Men or postmenopausal women aged 60-80 years
Willingness to provide written informed consent
Stable weight over preceding 6 weeks
Body Mass index (BMI) 22-28 kg/m2
Physically and psychologically healthy

Key exclusion criteria (22 listed)

Medications that interfere with the adrenal or gonadal axis will be excluded
Unable or unwilling to provide IRB (Internal Review Board)-approved informed consent
Clinical disorders and/or illnesses
Current medical or drug treatment, as assessed by questionnaire
History of brain injury or of learning disability

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketoconazole Pill (also known as nizoral)Ketoconazole pill is taken 4 times per inpatient visit	Drug	Pituitary Condition
GanirelixGanirelix subcutaneous injection is administered twice per inpatient visit	Drug	Adrenal/Testis Condition, Hypothalamic Condition
Dexamethasone PillDexamethasone pills is taken twice per inpatient visit	Drug	Adrenal/Testis Condition
Dexamethasone injectionDexamethasone IV injection is given twice per inpatient visit	Drug	Hypothalamic Condition
Cosyntropin Injectable ProductCosyntropin injection is given twice per inpatient visit	Drug	Adrenal/Testis Condition
Recombinant Human Luteinizing Hormone (also known as luveris)Recombinant Human Luteinizing Hormone is given as 6 IV infusion pulses per inpatient visit	Drug	Adrenal/Testis Condition
Hydrocortisone Injection (also known as solu-cortef)Hydrocortisone IV push is given twice per inpatient visit	Drug	Pituitary Condition
Gonadorelin (also known as Lutrepulse)Gonadorelin IV injection is given twice per inpatient visit	Drug	Adrenal/Testis Condition, Control Condition, Hypothalamic Condition, Pituitary Condition
Corticorelin (also known as Acthrel)Corticorelin IV injection is given twice per inpatient visit	Drug	Adrenal/Testis Condition, Control Condition, Hypothalamic Condition, Pituitary Condition
Placebo oral tabletPlacebo for Ketoconazole are given 4 times per inpatient visit	Drug	Control Condition, Hypothalamic Condition
Saline SolutionSaline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per inpatient visit	Drug	Control Condition, Pituitary Condition
Saline solution for injectionSaline Solution (placebo) for ganirelix subcutaneous injection	Drug	Control Condition, Hypothalamic Condition

Primary outcome

Average Blood Cortisol Concentration
Time frame: 5 days
Cortisol is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.
Average Blood Testosterone Concentration
Time frame: 5 days
Testosterone is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.

11 secondary outcomes

Peak Blood Cortisol Concentration
Time frame: 5 days
Peak Blood Testosterone Concentration
Time frame: 5 days
Trough Blood Cortisol Concentration
Time frame: 5 days
Trough Blood Testosterone Concentration
Time frame: 5 days
Reaction time on Psychomotor Vigilance Task
Time frame: 5 days
Karolinska Sleepiness Scale
Time frame: 5 days
Two card gambling task
Time frame: 5 days
Modified Sternberg working memory test
Time frame: 5 days
Caloric Intake
Time frame: 5 days
Hunger
Time frame: 5 days
Food Cravings
Time frame: 5 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Sleep Restriction

Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Active, not recruitingEarly Phase 1
Sleep and Inflammatory Resolution Pathway
Inflammatory Response, Inflammation
Active, not recruiting
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Prediabetes
Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Obesity (BMI Equal to or >30), Postmenopausal Symptoms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Liu, MD, PhD principal investigator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Blood Cortisol Concentration (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04037605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.