| NCT ID | NCT05775627 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Sleep Deprivation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-12-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to uncover sleep and circadian mechanisms contributing to adverse metabolic health. The protocol is a 21 day (7 outpatient days, 14 inpatient days) mechanistic randomized-crossover study designed to identify the impact of chronic sleep restriction and circadian timing, independently and in combination on energy metabolism and identify the independent and combined effects on glucose tolerance.
Eligibility Criteria
Inclusion Criteria: * Between 18 and 40 years of age * Drug free * Established disease-free status Exclusion Criteria: 1. Dietary restrictions Participants must not have dietary restrictions that could systematically bias their macronutrient intake. The following will exclude participants from enrolling in the study based on their diet: * Participants who choose not to or cannot consume dairy products (milk, yogurt, cheese, ice cream) 2. Body Composition A body mass index (BMI) of 18.5\< \[BMI\] \< 25 kg/m2 and a waist circumference \<94/80cm. 3. Psychiatric/psychological suitability Each participant will undergo a structured interview (Mini International Neuropsychiatric Interview) with a qualified OHSU physician. This physician will supervise the administration and scoring of a Beck Depression Inventory II (BDI-II) questionnaire for each potential participant. The following will exclude individuals from participating based on their psychiatric or psychological evaluation: * Individuals with evidence of psychopathology on the BDI-II, or in a structured clinical interview with the physician * A history of severe psychiatric illnesses * Alcoholism * Drug dependency * Major depression * Manic depressive illness * Schizophrenic disorders * Panic disorder * Generalized anxiety disorder * Post-traumatic stress disorder * Agoraphobia * Claustrophobia * Paranoid personality disorder * Schizoid personality disorder * Schizotypal personality disorder * Borderline personality disorder * Antisocial personality disorder. * History of using antidepressant medication * History of using neuroleptic medication * History of using tranquilizers 4. Drug/alcohol use Volunteers must be drug-free (including caffeine, nicotine, alcohol and herbal medications) for the entire duration of the outpatient and in-laboratory study period, with no history of drug or alcohol dependency. All participants must be: * Current non-smokers, and are required to have a history of less than 5 'pack years' of smoking 5. Medication/drug use Volunteers must not be taking any prescribed medications or over the counter medications, with an exception for birth control. 6. Prior shift work For stability of endogenous circadian rhythmicity, volunteers must have no history of the following 1 year prior to the study: * Working irregular day and night hours * Regular night work * Rotating shift work f * Not have traveled more than 1 time zone during 3 months prior to the study 7. Chronobiologic and sleep disorders * Hypernychthemeral sleep/wake cycle * Delayed sleep phase syndrome (wake time \> 2 hours later than desired or habitually after 10:00 AM) * Advanced sleep phase syndrome (wake time \> 2 h earlier than desired or habitually before 5:00 AM) * Narcolepsy * Sleep apnea (apnea index \>15) * Insomnia (sleep complaint by history or polygraphically recorded sleep efficiency \< 80%) * Hypersomnia * Periodic Limb Movement (PLMS) (PLMS index \>15) * Nocturnal Paroxysmal Dystonia * REM-sleep behavior disorder * Nocturnal Enuresis; (self-report and first night in the laboratory) * Obstructive sleep apnea (apnea/hypopnea index \>5/h as determined by at-home monitoring) * The investigators will also exclude individuals with extreme chronotype using the Horne-Ostberg Morningness/Eveningness questionnaire (i.e., the Owl/Lark Questionnaire) 8. Diseases of the Cardiovascular System * Hypertension (systolic blood pressure \> 140 or diastolic blood pressure \> 90) * Heart failure * Cardiomyopathy * Cor pulmonale * Ischemic heart disease * Valvular heart disease * History of heart transplantation * Cardiac tumors * Pericardial disease 9. Metabolic Syndrome Following American Heart Association cutoffs, participants who have, in addition to abdominal fat (obese exclusion criteria), two or more of these factors will be excluded from the study: * HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women * Systolic blood pressure \>135 mmHg or diastolic blood pressure \>85 mmHg * Fasting blood glucose ≥ 100 mg/dL * Triglycerides ≥ 150 mg/dL 10. Pre-Diabetes/Diabetes For participants who have a fasting blood glucose level of ≥ 100 mg/dL the investigators will measure hemoglobin A1c to exclude for diabetes (HbA1c\>5.7%). 11. Hypertension An upper cut off of 140/90 mmHg during an office blood pressure measure will be used as an exclusion criterion. After 5 minutes of rest in a seated position, blood pressure will be measured 3 times, taken 1 minute apart. The average will be used to confirm eligibility criteria. Current or history of beta blocker use will also be exclusionary. 12. Disorders of the Respiratory System * Asthma * Cystic fibroses * Chronic bronchitis * Emphysema * Airway obstruction * Interstitial lung diseases * Pulmonary hypertension * Lung neoplasms * ARDS 13. Disorders of the Kidney and Urinary Tract * Acute or chronic renal failure * History of renal transplantation * Tubulointerstitial diseases of the kidney * Urinary tract obstruction * Tumors of the urinary tract 14. Infectious Diseases * Infective endocarditis * HIV infection * Sexually transmitted diseases \[e.g., syphilis (including congenital syphilis and its sequelae), gonorrhea\], * Urinary tract infection * Osteomyelitis * Brucellosis * Toxoplasmosis, * Tuberculosis * Leptospirosis * Lyme disease * Mononucleosis * Hepatitis * Parasitic infections such as malaria, toxoplasmosis, giardiasis, schistosomiasis, leishmaniasis 15. Disorders of the Gastrointestinal System * Esophagitis * Peptic ulcer and gastritis * Neoplasms of the esophagus, stomach or bowel * Disorders of absorption * Inflammatory bowel disease * Diseases of the small and large intestine * Acute appendicitis * Cirrhosis or neoplasms of the liver * History of liver transplantation * Diseases of the gallbladder and bile ducts * Pancreatic disease 16. Disorders of the Immune System, Connective Tissue and Joints * AIDS * Systemic lupus erythematosus * Rheumatoid arthritis * Scleroderma * Ankylosing spondylitis * Vasculitis * Sarcoidosis 17. Disorders of the Hematopoietic System * Anemia * Leukemia * Myeloproliferative diseases * History of bone marrow transplantation 18. Neoplastic Diseases * Lymphoma * Carcinoma * Melanoma * Any other neoplastic diseases 19. Endocrine and Metabolic Diseases * Thyroid disease * Addison's Disease * Cushing's Syndrome * Aldosteronism * Hypoaldosteronism * Pheochromocytoma * Disorders of sexual differentiation that require hormone supplementation that may alter body weight * Disorders of neuroendocrine regulation * Diseases of the anterior pituitary and hypothalamus * Hemochromatosis porphyria * Wilson's Disease * Glycogen storage diseases * Diseases of the parathyroid gland * Metabolic bone disease * Disorders of phosphorus or magnesium metabolism * Paget's Disease 20. Neurologic Disorders * Epilepsy and disorders of consciousness * Dementia * Amnesic disorders * Neoplastic diseases of the central nervous system * Demyelinating diseases * Parkinson's Disease * Muscular dystrophy * Myasthenia gravis * Periodic paralysis * Dermatomyositis * Polymyositis * Infections of the nervous system * Stroke * History of transient ischemic attacks * Hydrocephalus * Tumors of the pituitary gland * Pinealoma * Intervertebral disc disease * Ataxia * Gilles de la Tourette Syndrome * Huntington's Disease * Tardive dyskinesia * History of recurrent migraine headaches * Neuromuscular disease. 21. Subjects must not be currently participating in another research study that would influence their safe participation in our study. Subjects must not be participating in a research study in which they do the following: * Ingest experimental medication * Give blood samples
Contact & Investigator
Andrew McHill, PhD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT05775627 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Sleep Deprivation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05775627 currently recruiting?
Yes, NCT05775627 is actively recruiting participants. Contact the research team at mchill@ohsu.edu for enrollment information.
Where is the NCT05775627 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05775627 clinical trial?
NCT05775627 is sponsored by Oregon Health and Science University. The principal investigator is Andrew McHill, PhD at Oregon Health and Science University. The trial plans to enroll 20 participants.