Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women (NCT04037605) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women
United States5 participantsStarted 2020-02-09
Plain-language 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 axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
Who can participate
Age range60 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Ir…
What they're measuring
1
Average Blood Cortisol Concentration
Timeframe: 5 days
2
Average Blood Testosterone Concentration
Timeframe: 5 days
Trial details
NCT IDNCT04037605
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center