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Trial · Interventional

Active, not recruitingEarly phase 1Registry data

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

NCTNCT04037605 (opens ClinicalTrials.gov in a new tab)Other idP31056-01R
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Early phase 1
Enrollment
5 participants (actual)
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
9 Feb 2020
Primary completion
24 Jul 2022
Completion
24 Jun 2026 (estimated)
First posted
30 Jul 2019
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
2020202220242026
  1. Ph Early 1

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

    NCT04037605

    9 Feb 2020 to est. 24 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 and 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 Pill (also known as nizoral)Drug
  • GanirelixDrug
  • Dexamethasone PillDrug
  • Dexamethasone injectionDrug
  • Cosyntropin Injectable ProductDrug
  • Recombinant Human Luteinizing Hormone (also known as luveris)Drug
  • Hydrocortisone Injection (also known as solu-cortef)Drug
  • Gonadorelin (also known as Lutrepulse)Drug
  • Corticorelin (also known as Acthrel)Drug
  • Placebo oral tabletDrug
  • 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 blood sample

  • Experimental

    Pituitary Condition

    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

  • Experimental

    Adrenal/Testis Condition

    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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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.

  2. 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)

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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'.

  8. 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.

  9. 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.

  10. Hunger

    Time frame · 5 days

    Registry description

    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.

  11. Food Cravings

    Time frame · 5 days

    Registry description

    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.

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
All
Age
from 60 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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