Status:
ACTIVE_NOT_RECRUITING
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Sleep Restriction
Eligibility:
All Genders
60-80 years
Phase:
EARLY_PHASE1
Brief Summary
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 ax...
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 res...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04037605
Start Date
February 9 2020
End Date
June 24 2026
Last Update
September 11 2025
Active Locations (1)
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1
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90509