Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease (NASHSAS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive; Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: OSA screening

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Please Select
    • Angers, Please Select, France, 49100
      • Recruiting
      • CHU Angers
      • Contact: Wojciech Trzepizur, MD PhD; Phone Number: +33 680575272; Email: wotrzepizur@chu-angers.fr
      • Sub-Investigator: Jérôme Boursier, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient suspected for NAFLD	Diagnostic test: OSA screening; Full night polysomnography

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Anticipated): December 14, 2019
• Study Completion (Anticipated): March 14, 2020

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Liver Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Fatty Liver; Apnea; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: UHAngers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No