Hormonal Mechanisms of Sleep Restriction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-08

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Sleep restriction increases evening cortisol and decreases testosterone. These are the main catabolic and anabolic hormones in men, respectively. This catabolic-anabolic imbalance likely leads to metabolic and reproductive ill-health. The hypothalamic-pituitary-end organ (adrenal or testis) mechanisms that must underpin these changes are unknown. 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 80 participants (assuming twenty different participant for each of the 4 clamp conditions) can be enrolled. However, participants will be allowed an opportunity to be randomized to all 4 conditions so that as few as 20 participants may be required. Urn randomization will be used to ensure that 20 different participants are involved in each of the 4 conditions.

Conditions

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Sleep Restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blood is sampled every 10 minutes from 4PM to 9PM for future mathematical deconvolution in order to determine hormone pulse characteristics in response to the clamp conditions. These values are the primary endpoints.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

3 of the 4 conditions are masked by use of identical injections and pills. However one condition (adrenal testis) is not masked. Hence the study is partially masked.

Study Groups

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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

Group Type EXPERIMENTAL

Gonadorelin

Intervention Type DRUG

Gonadorelin IV injection is given twice per Inpatient Stay

Corticorelin

Intervention Type DRUG

Corticorelin IV injection is given twice per Inpatient Stay

Placebo oral capsule

Intervention Type DRUG

Placebo for ketoconazole are given 4 times per Inpatient Stay

Saline Solution

Intervention Type DRUG

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

Saline Solution for Injection

Intervention Type DRUG

Saline Solution (placebo) for ganirelix subcutaneous injection

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

Group Type EXPERIMENTAL

Ganirelix

Intervention Type DRUG

Ganirelix subcutaneous injection is administered twice per Inpatient Stay

Dexamethasone Injection

Intervention Type DRUG

Dexamethasone IV injection is given twice per Inpatient Stay

Gonadorelin

Intervention Type DRUG

Gonadorelin IV injection is given twice per Inpatient Stay

Corticorelin

Intervention Type DRUG

Corticorelin IV injection is given twice per Inpatient Stay

Placebo oral capsule

Intervention Type DRUG

Placebo for ketoconazole are given 4 times per Inpatient Stay

Saline Solution for Injection

Intervention Type DRUG

Saline Solution (placebo) for ganirelix subcutaneous injection

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

Group Type EXPERIMENTAL

Ketoconazole Pill

Intervention Type DRUG

Ketoconazole pill is taken 4 times per Inpatient Stay

Hydrocortisone Injection

Intervention Type DRUG

Hydrocortisone IV push is given twice per Inpatient Visit

Gonadorelin

Intervention Type DRUG

Gonadorelin IV injection is given twice per Inpatient Stay

Corticorelin

Intervention Type DRUG

Corticorelin IV injection is given twice per Inpatient Stay

Saline Solution

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Ganirelix

Intervention Type DRUG

Ganirelix subcutaneous injection is administered twice per Inpatient Stay

Dexamethasone

Intervention Type DRUG

Dexamethasone Pills is taken twice per Inpatient Stay

Cosyntropin Injectable Product

Intervention Type DRUG

cosyntropin injection is given twice per Inpatient Stay

Recombinant Human Luteinizing Hormone

Intervention Type DRUG

Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit

Gonadorelin

Intervention Type DRUG

Gonadorelin IV injection is given twice per Inpatient Stay

Corticorelin

Intervention Type DRUG

Corticorelin IV injection is given twice per Inpatient Stay

Interventions

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Ketoconazole Pill

Ketoconazole pill is taken 4 times per Inpatient Stay

Intervention Type DRUG

Ganirelix

Ganirelix subcutaneous injection is administered twice per Inpatient Stay

Intervention Type DRUG

Dexamethasone

Dexamethasone Pills is taken twice per Inpatient Stay

Intervention Type DRUG

Dexamethasone Injection

Dexamethasone IV injection is given twice per Inpatient Stay

Intervention Type DRUG

Cosyntropin Injectable Product

cosyntropin injection is given twice per Inpatient Stay

Intervention Type DRUG

Recombinant Human Luteinizing Hormone

Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit

Intervention Type DRUG

Hydrocortisone Injection

Hydrocortisone IV push is given twice per Inpatient Visit

Intervention Type DRUG

Gonadorelin

Gonadorelin IV injection is given twice per Inpatient Stay

Intervention Type DRUG

Corticorelin

Corticorelin IV injection is given twice per Inpatient Stay

Intervention Type DRUG

Placebo oral capsule

Placebo for ketoconazole are given 4 times per Inpatient Stay

Intervention Type DRUG

Saline Solution

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

Intervention Type DRUG

Saline Solution for Injection

Saline Solution (placebo) for ganirelix subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Nizoral Luveris solu-cortef Lutrepulse Acthrel

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes