Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver

NCT01849081 | Withdrawn DMC FDA Device

• 1 other identifier: 2013P000688
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We are doing this research study to evaluate whether continuous positive airway pressure (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea is a disease where a person has interruptions in their breathing while they are sleep. This can lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high pressure to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known treatment for sleep apnea.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver disease; Obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Steatosis by MRS

  Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.

  12 weeks

Study Arms (2)

CPAP

EXPERIMENTAL

Subjects in this arm with receive treatment with CPAP for fatty liver disease.

Device: CPAP

Lifestyle Intervention

ACTIVE COMPARATOR

Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.

Behavioral: LIfestyle

Interventions

CPAP DEVICE

Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.

CPAP

LIfestyle BEHAVIORAL

Subjects will undergo 12 weeks of dietary counseling.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older with a previous liver biopsy showing NASH and at least grade 2 steatosis
• Obstructive sleep apnea diagnosed by sleep study.

You may not qualify if:

• Other causes of chronic liver disease
• cirrhosis
• less than 33% steatosis identified on magnetic resonance spectroscopy (MRS)
• Alcohol use \>2 units per day for women or \>3 units per day for men
• Intolerance to or refusal of CPAP therapy
• overnight desaturation (more than 10% of the sleep time with oxygen desaturation below 85%)
• underlying sever sleepiness (Epworth scale more than 15)
• uncontrolled hypertension
• Severe heart failure (ejection fracture less than 30%)
• cardiac arrhythmias (atrial fibrillation or history of ventricular tachycardia)
• those who are commercial drivers

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kathleen E Corey, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

US (1)