Hormonal Mechanisms of Sleep Restriction - Axis Study

NCTNCT03142893Other id30068-01A

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Overview

Status: Active, not recruiting
Phase: Phase 1
Enrollment: 80 participants (estimated)
Sponsor: Peter y. Liu · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: 8 May 2017
Primary completion: 30 Oct 2020
Completion: 30 Jun 2026 (estimated)
First posted: 8 May 2017
Last update posted: 11 Sept 2025
Conditions: Sleep Restriction

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182020202220242026

Ph 1
Hormonal Mechanisms of Sleep Restriction - Axis Study
NCT03142893
8 May 2017 to est. 30 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Ketoconazole PillDrug
GanirelixDrug
DexamethasoneDrug
Dexamethasone InjectionDrug
Cosyntropin Injectable ProductDrug
Recombinant Human Luteinizing HormoneDrug
Hydrocortisone InjectionDrug
GonadorelinDrug
CorticorelinDrug
Placebo oral capsuleDrug
Saline SolutionDrug
Saline Solution for InjectionDrug

Arms4

Experimental
Control Condition
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
Experimental
Hypothalamic Condition
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
Experimental
Pituitary Condition
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
Experimental
Adrenal/Testis Condition
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

Primary outcomes2

Outcomes the sponsor listed as primary.

Average Blood Cortisol Concentration
Time frame · 5 days
Registry description
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
Registry description
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.

Secondary outcomes(11)

Peak Blood Cortisol Concentration
Time frame · 5 days
Registry description
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.
Peak Blood Testosterone Concentration
Time frame · 5 days
Registry description
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.
Trough Blood Cortisol Concentration
Time frame · 5 days
Registry description
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.
Trough Blood Testosterone Concentration
Time frame · 5 days
Registry description
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.
Reaction time on Psychomotor Vigilance Task
Time frame · 5 days
Registry description
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.
Karolinska Sleepiness Scale
Time frame · 5 days
Registry description
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.
Two card gambling task
Time frame · 5 days
Registry description
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects participants' decision making. The end point is discriminability index, d'.
Modified Sternberg working memory test
Time frame · 5 days
Registry description
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects reaction time and accuracy.
Caloric Intake
Time frame · 5 days
Registry description
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.
Hunger Scale
Time frame · 5 days
Registry description
Hunger scale using Flint visual analogue scale to assess how 4 nights of sleep restriction affects participants' appetite.
Food Cravings
Time frame · 5 days
Registry description
Food cravings is measured using Food Cravings Index scale to assess which food groups participants have cravings for and how their cravings change during 4 nights of sleep restriction.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 22 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Men aged 22-45 years * Willingness to provide written informed consent * Stable weight over preceding 6 weeks * Body Mass index (BMI) 20-28 kg/m2 Exclusion Criteria: * 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 * 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

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