Evaluating the Efficacy of CPAP Therapy for the Treatment... | NCT01849081

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

NCT01849081

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Oct 6, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

CPAP
LIfestyle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change in priorities, study closed prior to enrollment

Expanded Access Info

Start Date

Mar 2019Estimated

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

May 6, 2013

First Submission Date that Met QC Criteria

May 7, 2013

First Posted Date

May 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2020

Last Update Posted Date

Oct 6, 2020Actual

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CPAP	Device	Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.	CPAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathleen E Corey, MD, MPH	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D012891	Sleep Apnea Syndromes

Browse Leaves

Not provided

Browse Branches

Not provided