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Sleep Restriction

Hormonal Mechanisms of Sleep Restriction - Axis Study

Sponsored by Peter y. Liu

About this trial

Last updated 8 months ago

Study ID

30068-01A

Status

Active not recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

22 to 45 Years
Male

Trial Timing

Started 9 years ago

What is this trial about?

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.

What are the participation requirements?

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