Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) and nonalcoholic fatty liver disease (NAFLD) are frequently encountered in patients with metabolic syndrome (MS). Several data suggest that OSA per se could be a risk factor of liver injury. Most previous studies evaluating the association between OSA severity and the severity of NAFLD used indirect markers of NAFLD including liver imaging or liver injury blood markers or have been performed in morbidly obese patients undergoing intraoperative needle liver biopsy during bariatric surgery. The current study propose to investigate with a full night polysomnography consecutive patients undergoing percutaneous liver biopsy for suspected NAFLD.

Official Title
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Association Between Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease Investigated by Liver Biopsy

Conditions
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Non-alcoholic Fatty Liver Disease, Sleep Apnea, Obstructive

Intervention / Treatment
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* Diagnostic Test: OSA screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected NAFLD requiring per-cutaneous liver biopsy Exclusion Criteria: Other than NAFLD liver disease Previously diagnosed or treated OSA Excessive alcohol consumption (>220 gr/week for men, >140 gr/week for women) Pregnancy Surgical treatment for obesity past history

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient suspected for NAFLD<br> | Diagnostic Test: OSA screening<br>* Full night polysomnography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant liver fibrosis (score F3 and F4 of the histological nonalcoholic steatohepatitis [NASH]-CRN classification) | Apnea hypopnea index per hour of sleep is investigated in each participant using full night polysomnography. Significant liver fibrosis will be considered if histological analysis conclude to a fibrosis score of 3 or more using the NASH-CRN classification (F3 and F4). | The polysomnography will be performed no more than 3 months after the liver biopsy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant nonalcoholic steatohepatitis (3 positive criteria on NASH-CRN classification) | Apnea hypopnea index per hour of sleep is investigated in each participant using full night polysomnography. Significant nonalcoholic steatohepatitis will be considered if histological analysis meets 3 positive criteria on NASH-CRN classification: steatosis score ≥ 1 and lobular inflammation score ≥ 1 and hepatocyte ballooning score ≥ 1. | The polysomnography will be performed no more than 3 months after the liver biopsy. | 
| Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant liver steatosis (histological steatosis > 33% or stade 2 or more on NASH-CRN) | Apnea hypopnea index per hour of sleep is investigated in each participant using full night polysomnography. Significant liver steatosis will be considered if histological analysis conclude to a histological steatosis of 30% or more or a stade 2 steatosis or more using the NASH-CRN classification. | The polysomnography will be performed no more than 3 months after the liver biopsy. |