Hormonal Mechanisms of Sleep Restriction - Axis Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 22 - 45 |
| Updated: | 8/9/2018 |
| Start Date: | May 8, 2017 |
| End Date: | May 1, 2020 |
| Contact: | Peter Liu, MD, PhD |
| Email: | pliu@labiomed.org |
| Phone: | 310-222-1867 |
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.
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.
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.
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.
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
We found this trial at
1
site
Torrance, California 90502
Principal Investigator: Peter Y Liu, MD PhD
Phone: 310-222-1860
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