Phase 2
N=9
The Sleep, Liver Evaluation and Effective Pressure Study
Non Alcoholic Fatty Liver Disease · Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01482065 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Cross Sectional Analysis of NAFLD Versus Sleep Apnea Severity Indices (AHI)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CPAP (ResMed S9 autoset CPAP) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cross Sectional Analysis of NAFLD Versus Sleep Apnea Severity Indices (AHI) |
— | — |
| SECONDARY Liver Values |
37.25; 53.8; 29; 40.5; 26.75; 32.6 | — |
| SECONDARY Analysis of Variance (ANOVA) in CPAP Versus No-CPAP Therapy on NAFLD |
— | — |
| SECONDARY MRI Indices |
10.57; 15.406; 8.69; 18.76 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 21
- Diagnosis of NAFLD and BMI ≥ 30 or obesity with BMI > 35 and 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.
Data sourced from ClinicalTrials.gov (NCT01482065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.