Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04037605
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2019-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'C061018', 'term': 'ganirelix'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D037101', 'term': 'Luteinizing Hormone, beta Subunit'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'C007133', 'term': 'hydrocortisone hemisuccinate'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D003346', 'term': 'Corticotropin-Releasing Hormone'}, {'id': 'C085671', 'term': 'corticorelin ovine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Blood is sampled every 10 minutes from 4 pm to 9 pm for future mathematical deconvolution in order to determine hormone pulse characteristics in response to the clamp conditions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-07-29', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Blood Cortisol Concentration', 'timeFrame': '5 days', 'description': 'Cortisol is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.'}, {'measure': 'Average Blood Testosterone Concentration', 'timeFrame': '5 days', 'description': 'Testosterone is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.'}], 'secondaryOutcomes': [{'measure': 'Peak Blood Cortisol Concentration', 'timeFrame': '5 days', 'description': 'This is the single maximal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.'}, {'measure': 'Peak Blood Testosterone Concentration', 'timeFrame': '5 days', 'description': 'This is the single maximal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.'}, {'measure': 'Trough Blood Cortisol Concentration', 'timeFrame': '5 days', 'description': 'This is the single minimal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.'}, {'measure': 'Trough Blood Testosterone Concentration', 'timeFrame': '5 days', 'description': 'This is the single minimal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.'}, {'measure': 'Reaction time on Psychomotor Vigilance Task', 'timeFrame': '5 days', 'description': 'This is measured by lapses in attention. As the person becomes more sleepy, there are more lapses (reaction time \\>500 ms), at the beginning and at the end of 4 nights of sleep restriction.'}, {'measure': 'Karolinska Sleepiness Scale', 'timeFrame': '5 days', 'description': 'Measures how sleepy participants are using a scale of 1 (extremely alert) through 9. This scale will be used to assess changes in sleepiness throughout the day and through 4 nights of sleep restriction.'}, {'measure': 'Two card gambling task', 'timeFrame': '5 days', 'description': "Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects participants' decision making. The end point is discriminability index, d'."}, {'measure': 'Modified Sternberg working memory test', 'timeFrame': '5 days', 'description': 'Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects reaction time and accuracy.'}, {'measure': 'Caloric Intake', 'timeFrame': '5 days', 'description': 'The food given to participants is weighed. The amount that is not consumed is also weighed. The difference in weight is the amount of calories consumed.'}, {'measure': 'Hunger', 'timeFrame': '5 days', 'description': "Hunger levels are assessed using the Flint visual analogue scale (VAS) to assess how 4 nights of sleep restriction affects participants' appetite.The Flint VAS asks the participant to rate 8 aspects of their hunger level on a scale from 1-5."}, {'measure': 'Food Cravings', 'timeFrame': '5 days', 'description': 'Food cravings are measured using the Food Cravings Index (FCI) scale to assess which food groups each participant has cravings for and how their cravings change during 4 nights of sleep restriction. The participant ranks their craving for 33 food items on a scale from 1-5.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Testosterone', 'Cortisol'], 'conditions': ['Sleep Restriction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 resistance. The mechanisms by which sleep restriction leads to increased insulin resistance are unknown, especially in vulnerable older adults; such research informs development of targeted interventions against the sleep loss/insulin resistance link.\n\nThis 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.\n\nUp to 40 participants can be enrolled. However, participants will be allowed an opportunity to be randomized to all 4 conditions so that as few as 10 participants may be required. We anticipate 5 men and 5 women will be enrolled assuming each undergoes all 4 clamp conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or postmenopausal women aged 60-80 years\n* Willingness to provide written informed consent\n* Stable weight over preceding 6 weeks\n* Body Mass index (BMI) 22-28 kg/m2\n* Physically and psychologically healthy\n* Good habitual sleep with regular bedtimes\n* Neither extreme morning- nor extreme evening-type using Horne-Ostberg Morningness-Eveningness criteria\n\nExclusion Criteria:\n\n* Medications that interfere with the adrenal or gonadal axis will be excluded\n* Unable or unwilling to provide IRB (Internal Review Board)-approved informed consent\n* Clinical disorders and/or illnesses\n* Current medical or drug treatment, as assessed by questionnaire\n* History of brain injury or of learning disability\n* Vision or hearing impairment unless corrected back to normal\n* Anemia (Hct \\<38%)\n* History of psychiatric illness\n* Clinically significant abnormalities in blood and urine, and free of traces of drugs\n* 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\n* Type 2 Diabetes (HgbA1C)\n* Current smoker\n* Recent or concurrent drug or alcohol abuse\n* Blood donation in previous eight weeks\n* Travel across time zones within one month of entering the study\n* Sleep or circadian disorder\n* Shift work within three months of entering the study\n* Irregular bedtimes (not between 6 and 10 hours in duration)\n* Unoperated obstructive uropathy, recurrent prostatitis, indeterminate prostatic nodularity, Hx or Suspicion of cancer of the prostate gland or PSA (prostate-specific antigen) \\>4ng/ml\n* Previous adverse reaction to sleep deprivation or any of the drugs to be administered\n* Concurrent participation in another research study\n* Mini- mental state examination (MMSE) \\< 27'}, 'identificationModule': {'nctId': 'NCT04037605', 'briefTitle': 'Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}, 'officialTitle': 'Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women', 'orgStudyIdInfo': {'id': 'P31056-01R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Condition', 'description': '8 am - Saline Solution for Injection\n\n10 am - Placebo oral capsule\n\n1 pm - Saline Solution for Injection\n\n4 pm - Placebo oral capsule \\& start hourly blood sampling\n\n7 pm- Gonadorelin (GnRH) and Corticorelin (CRH) injections\n\n9 pm - Saline Solution for Injection \\& last blood sample', 'interventionNames': ['Drug: Gonadorelin (also known as Lutrepulse)', 'Drug: Corticorelin (also known as Acthrel)', 'Drug: Placebo oral tablet', 'Drug: Saline Solution', 'Drug: Saline solution for injection']}, {'type': 'EXPERIMENTAL', 'label': 'Hypothalamic Condition', 'description': '8 am -Ganirelix\n\n10 am - Placebo oral capsule\n\n1 pm - Dexamethasone injection\n\n4 pm- Placebo oral capsule and start of hourly blood sampling\n\n7 pm - GnRH and CRH injections\n\n9 pm - Saline Solution for Injection and last sample blood sample', 'interventionNames': ['Drug: Ganirelix', 'Drug: Dexamethasone injection', 'Drug: Gonadorelin (also known as Lutrepulse)', 'Drug: Corticorelin (also known as Acthrel)', 'Drug: Placebo oral tablet', 'Drug: Saline solution for injection']}, {'type': 'EXPERIMENTAL', 'label': 'Pituitary Condition', 'description': '8 am - Saline Solution for Injection\n\n10 am - Ketoconazole Pill\n\n1 pm - Saline Solution for Injection\n\n4 pm - Ketoconazole Pill \\& start of hourly blood sampling\n\n7 pm - GnRH and CRH\n\n9 pm - Hydrocortisone Injection and last blood sample', 'interventionNames': ['Drug: Ketoconazole Pill (also known as nizoral)', 'Drug: Hydrocortisone Injection (also known as solu-cortef)', 'Drug: Gonadorelin (also known as Lutrepulse)', 'Drug: Corticorelin (also known as Acthrel)', 'Drug: Saline Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Adrenal/Testis Condition', 'description': '10 pm - Ganirelix Injection \\& Dexamethasone Pills (night before)\n\n8 am - Start of hourly blood sampling\n\n10 am - Dexamethasone Pills\n\n11 am - Last hourly blood sample taken\n\n11:30 am - Start of blood sampling every 10 minutes\n\n1 pm - Recombinant Human Luteinizing Hormone (rhLH) Injection\n\n3 pm - rhLH Injection\n\n5 pm - rhLH Injection\n\n5 pm - Cosyntropin Injectable product\n\n7 pm - GnRH and CRH Injections\n\n9 pm - Last blood sample', 'interventionNames': ['Drug: Ganirelix', 'Drug: Dexamethasone Pill', 'Drug: Cosyntropin Injectable Product', 'Drug: Recombinant Human Luteinizing Hormone (also known as luveris)', 'Drug: Gonadorelin (also known as Lutrepulse)', 'Drug: Corticorelin (also known as Acthrel)']}], 'interventions': [{'name': 'Ketoconazole Pill (also known as nizoral)', 'type': 'DRUG', 'description': 'Ketoconazole pill is taken 4 times per inpatient visit', 'armGroupLabels': ['Pituitary Condition']}, {'name': 'Ganirelix', 'type': 'DRUG', 'description': 'Ganirelix subcutaneous injection is administered twice per inpatient visit', 'armGroupLabels': ['Adrenal/Testis Condition', 'Hypothalamic Condition']}, {'name': 'Dexamethasone Pill', 'type': 'DRUG', 'description': 'Dexamethasone pills is taken twice per inpatient visit', 'armGroupLabels': ['Adrenal/Testis Condition']}, {'name': 'Dexamethasone injection', 'type': 'DRUG', 'description': 'Dexamethasone IV injection is given twice per inpatient visit', 'armGroupLabels': ['Hypothalamic Condition']}, {'name': 'Cosyntropin Injectable Product', 'type': 'DRUG', 'description': 'Cosyntropin injection is given twice per inpatient visit', 'armGroupLabels': ['Adrenal/Testis Condition']}, {'name': 'Recombinant Human Luteinizing Hormone (also known as luveris)', 'type': 'DRUG', 'description': 'Recombinant Human Luteinizing Hormone is given as 6 IV infusion pulses per inpatient visit', 'armGroupLabels': ['Adrenal/Testis Condition']}, {'name': 'Hydrocortisone Injection (also known as solu-cortef)', 'type': 'DRUG', 'description': 'Hydrocortisone IV push is given twice per inpatient visit', 'armGroupLabels': ['Pituitary Condition']}, {'name': 'Gonadorelin (also known as Lutrepulse)', 'type': 'DRUG', 'description': 'Gonadorelin IV injection is given twice per inpatient visit', 'armGroupLabels': ['Adrenal/Testis Condition', 'Control Condition', 'Hypothalamic Condition', 'Pituitary Condition']}, {'name': 'Corticorelin (also known as Acthrel)', 'type': 'DRUG', 'description': 'Corticorelin IV injection is given twice per inpatient visit', 'armGroupLabels': ['Adrenal/Testis Condition', 'Control Condition', 'Hypothalamic Condition', 'Pituitary Condition']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Placebo for Ketoconazole are given 4 times per inpatient visit', 'armGroupLabels': ['Control Condition', 'Hypothalamic Condition']}, {'name': 'Saline Solution', 'type': 'DRUG', 'description': 'Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per inpatient visit', 'armGroupLabels': ['Control Condition', 'Pituitary Condition']}, {'name': 'Saline solution for injection', 'type': 'DRUG', 'description': 'Saline Solution (placebo) for ganirelix subcutaneous injection', 'armGroupLabels': ['Control Condition', 'Hypothalamic Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Biomedical Research Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}], 'overallOfficials': [{'name': 'Peter Liu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter y. Liu', 'investigatorAffiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}}}}