Status:
COMPLETED
The Sleep, Liver Evaluation and Effective Pressure Study
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
ResMed Foundation
Conditions:
Non Alcoholic Fatty Liver Disease
Obstructive Sleep Apnea
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
This research is being done to examine: 1) how common obstructive sleep apnea (OSA) is in patients with non-alcoholic fatty liver disease (NAFLD), 2) whether the severity of OSA is related to the seve...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD) is a common disease with a well-established link to obesity and is increasingly prevalent with the concurrent rise in obesity. NAFLD constitutes a disease spec...
Eligibility Criteria
Inclusion
- Age ≥ 21
- Diagnosis of NAFLD and BMI ≥ 30 or obesity with BMI \> 35 and \< 400lbs
- No other cause of liver disease other than NAFLD (as assessed by patient and physician surveys detailed below, blood work and magnetic resonance imaging(MRI))
Exclusion
- Both patients and doctors will be asked to identify potential exclusionary conditions including:
- Patients with sickle cell anemia, hemoglobinopathies and other hemolytic anemias
- Known clinical hypersensitivity or a history of asthma or allergic respiratory disorders
- Advanced renal failure (currently requiring dialysis or with a Glomerular Filtration rate \< 30cc/min)
- Pregnancy
- History of CPAP treatment for OSA
- Recent weight loss (6 months) ≥ 10%
- Current alcohol use \> 20 g/day in women and \> 30 g/day in men, or prior use for ≥ 3 consecutive months during the previous 5 years as assessed with the Lifetime Drinking History Questionnaire Viral hepatitis A, B and C
- Autoimmune hepatitis
- Hemochromatosis
- Wilson's disease
- Alpha-1-antitrypsin deficiency
- Primary sclerosing cholangitis
- Cirrhosis of any etiology
- History of HIV infection and/or HAART therapy
- Evidence of drug-induced liver injury
- Use of systemic steroids for \> 10 days during prior 6 months
- Unstable cardiovascular disease (decompensated chronic heart failure (CHF), myocardial infarction or revascularization procedures, unstable arrhythmias)
- Uncontrolled hypertension with BP \> 190/110
- Daytime hypoxemia with oxygen saturation (SaO2)\<90%
- Supplemental oxygen use
- Presence of any contraindication to MR examinations (see MRI Safety Screening Sheet)
- History of Metal in the Skull/Eyes
- Unable to have an MRI Scan
- Severe daytime hypersomnolence as defined by an Epworth Sleepiness Score of greater than 10.
- Severe sleep apnea as characterized by an apnea-hypopnea index of greater than 80 episodes/hour or an average low SaO2 during sleep disordered breathing episodes below 80%.
- Work in transportation industry as a driver or pilot.
- Patients with a diagnosis of sleep apnea on active treatment.
- Exclusions based on etiology of hepatitis will be assessed by querying both the hepatology list and patient about the above mentioned disorders (#7-15) and through testing for viral hepatitis A, B, C, ferritin, antinuclear antibody (ANA), antineutrophil cytoplasmic antibody (ANCA), anti-mitochondrial antibody, anti-smooth muscle antibody and ceruloplasmin.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01482065
Start Date
November 1 2011
End Date
October 1 2015
Last Update
January 4 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21224