The Sleep, Liver Evaluation and Effective Pressure Study

Completed · Phase 2

Conditions studied: Non Alcoholic Fatty Liver Disease, Obstructive Sleep Apnea

In brief

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 severity of NAFLD, and 3) whether treatment of OSA with continuous positive airway pressure (CPAP) improved NAFLD progression. OSA is a condition caused by repetitive collapse of throat tissue during sleep that leads to falls in oxygen level and sleep disruption. OSA can be caused by obesity, and especially by fat found in the neck and belly. NAFLD is a common disease linked to obesity. NAFLD is part of a disease spectrum, which can progress from steatosis (fatty liver) to nonalcoholic steatohepatitis (NASH), a progressive fibrotic disease, in which cirrhosis and liver-related death can occur. Recent evidence in patients with obstructive sleep apnea (OSA) indicates that OSA is associated with NASH. How common OSA is in patients with biopsy-confirmed NAFLD and the effect of OSA treatment with CPAP on NASH is unknown.

Key facts

Study ID

NCT01482065

Run by

Johns Hopkins University

People needed

40

Starts

2011-11-01

Expected to finish

2015-10-01

Last updated by the study team

2017-01-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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