BridgeMD
New treatment option for Sleep Deprivation
Official title Sleep and Metabolism
ClinicalTrials.gov ID: NCT05775627
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- Between 18 and 40 years of age
- Drug free
- Established disease-free status
You likely can't join if
- Dietary restrictions Participants must not have dietary restrictions that could systematically bias their macronutrient intake. The following will...
- Participants who choose not to or cannot consume dairy products (milk, yogurt, cheese, ice cream)
- Body Composition A body mass index (BMI) of 18.5\< [BMI] \< 25 kg/m2 and a waist circumference \<94/80cm.
- Psychiatric/psychological suitability Each participant will undergo a structured interview (Mini International Neuropsychiatric Interview) with a...
- Individuals with evidence of psychopathology on the BDI-II, or in a structured clinical interview with the physician
- A history of severe psychiatric illnesses
See the full eligibility criteria
Who can join
- Between 18 and 40 years of age
- Drug free
- Established disease-free status
What rules you out
- 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)
- Body Composition A body mass index (BMI) of 18.5\< [BMI] \< 25 kg/m2 and a waist circumference \<94/80cm.
- Psychiatric/psychological suitability Each participant will undergo a structured interview (Mini International Neuropsychiatric Interview) with a qualified OHSU physician. This physician will supervise the...
- 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
- 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...
- Current non-smokers, and are required to have a history of less than 5 'pack years' of smoking
- Medication/drug use Volunteers must not be taking any prescribed medications or over the counter medications, with an exception for birth control.
- 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
- 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)
- 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
- 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
- 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%).
- 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...
- Disorders of the Respiratory System
- Asthma
- Cystic fibroses
- Chronic bronchitis
- Emphysema
- Airway obstruction
- Interstitial lung diseases
- Pulmonary hypertension
- Lung neoplasms
- ARDS
- 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
- 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
- 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
- Disorders of the Immune System, Connective Tissue and Joints
- AIDS
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Scleroderma
- Ankylosing spondylitis
- Vasculitis
- Sarcoidosis
- Disorders of the Hematopoietic System
- Anemia
- Leukemia
- Myeloproliferative diseases
- History of bone marrow transplantation
- Neoplastic Diseases
- Lymphoma
- Carcinoma
- Melanoma
- Any other neoplastic diseases
- 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
- 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.
- people must not be currently participating in another research study that would influence their safe participation in our study. people must not be participating in a research study in which they do the following:
- Ingest experimental medication
- Give blood samples
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.