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NCT04037605·Early Phase 1·INTERVENTIONAL

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

GanirelixOtherActive, not recruiting

Status

Active, not recruiting

Phase

Early Phase 1

Enrollment

5

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Ketoconazole Pill (also known as nizoral)

Ketoconazole pill is taken 4 times per inpatient visit

DRUG

Ganirelix

Ganirelix subcutaneous injection is administered twice per inpatient visit

DRUG

Dexamethasone Pill

Dexamethasone pills is taken twice per inpatient visit

DRUG

Dexamethasone injection

Dexamethasone IV injection is given twice per inpatient visit

DRUG

Cosyntropin Injectable Product

Cosyntropin injection is given twice per inpatient visit

DRUG

Recombinant Human Luteinizing Hormone (also known as luveris)

Recombinant Human Luteinizing Hormone is given as 6 IV infusion pulses per inpatient visit

DRUG

Hydrocortisone Injection (also known as solu-cortef)

Hydrocortisone IV push is given twice per inpatient visit

DRUG

Gonadorelin (also known as Lutrepulse)

Gonadorelin IV injection is given twice per inpatient visit

DRUG

Corticorelin (also known as Acthrel)

Corticorelin IV injection is given twice per inpatient visit

DRUG

Placebo oral tablet

Placebo for Ketoconazole are given 4 times per inpatient visit

DRUG

Saline Solution

Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per inpatient visit

DRUG

Saline solution for injection

Saline Solution (placebo) for ganirelix subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Jul 30, 2019

  2. Study start

    Feb 9, 2020

  3. Primary completion

    Jul 24, 2022

  4. Study completion

    Jun 24, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Sep 11, 2025

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Peak Blood Cortisol Concentration

Time frame · 5 days

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

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

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

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

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

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

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

Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects reaction time and accuracy.

Caloric Intake

Time frame · 5 days

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

Time frame · 5 days

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.

Eligibility

Who can take part.

Minimum age
60 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
Yes

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Los Angeles Biomedical Research Institute

Torrance, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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