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The Role of Obstructive Sleep Apnea in Children With Fatty Liver Disease

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: NCT02134522
Recruitment Status : Terminated (We were not able to recruit participants.)
First Posted : May 9, 2014
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Alcoholic Fatty Liver Disease
Intervention Device: Continuous positive airway pressure (CPAP).
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title C-pap Intervention
Hide Arm/Group Description Subjects who underwent measurement of the hepatic fat content before and after the C-pap
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title C-pap Intervention
Hide Arm/Group Description Subjects undergoing measurements of hepatic fat content before and after C-pap
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Number Analyzed 1 participants
Female 0
Male 1
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
1
 100.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Changes in Hepatic Fat Content
Hide Description Abdominal MRI to measure percent liver fat done at baseline and 12 weeks.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Presented is the change from baseline to 12 weeks in a single patient.
Arm/Group Title C-pap Intervention
Hide Arm/Group Description:
Subjects who underwent the measure of hepatic fat content before and after the C-pap
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: percentage of hepatic liver fat
-4.8
2.Secondary Outcome
Title Changes in Two Hour Glucose
Hide Description 2 hour glucose measured by an oral glucose tolerance test done at baseline and 12 weeks. Data are presented as mg/dl.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title C-pap Intervention
Hide Arm/Group Description:
Subjects who underwent the measure of hepatic fat content before and after the C-pap
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: mg/dl
5
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title C-PAP Intervention
Hide Arm/Group Description

Continuous positive airway pressure is a commonly prescribed therapy for obstructive sleep apnea which is recommended for the treatment of obstructive sleep apnea in children and adults.

Continuous positive airway pressure (CPAP).: Continuous positive airway pressure is a commonly prescribed therapy for obstructive sleep apnea which is recommended for the treatment of obstructive sleep apnea in children and adults.

All-Cause Mortality
C-PAP Intervention
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Serious Adverse Events
C-PAP Intervention
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
C-PAP Intervention
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicola Santoro
Organization: Yale University
Phone: 2037376356
EMail: nicola.santoro@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02134522    
Other Study ID Numbers: 1404013732
First Submitted: May 7, 2014
First Posted: May 9, 2014
Results First Submitted: February 21, 2018
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018