Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373643
Recruitment Status : Unknown
Verified January 2019 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : December 14, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Sleep Apnea, Obstructive Diagnostic Test: OSA screening Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Association Between Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease Investigated by Liver Biopsy
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : December 14, 2019
Estimated Study Completion Date : March 14, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Patient suspected for NAFLD Diagnostic Test: OSA screening
Full night polysomnography


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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) [ Time Frame: The polysomnography will be performed no more than 3 months after the liver biopsy. ]

    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).



Secondary Outcome Measures :
  1. Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant nonalcoholic steatohepatitis (3 positive criteria on NASH-CRN classification) [ Time Frame: The polysomnography will be performed no more than 3 months after the liver biopsy. ]

    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.


  2. 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) [ Time Frame: The polysomnography will be performed no more than 3 months after the liver biopsy. ]

    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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373643


Locations
Layout table for location information
France
CHU Angers Recruiting
Angers, Please Select, France, 49100
Contact: Wojciech Trzepizur, MD PhD    680575272 ext +33    wotrzepizur@chu-angers.fr   
Sub-Investigator: Jérôme Boursier, MD PhD         
Sponsors and Collaborators
University Hospital, Angers
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03373643    
Other Study ID Numbers: UHAngers
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Digestive System Diseases