We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Sleep, Liver Evaluation and Effective Pressure Study (SLEEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482065
First Posted: November 30, 2011
Last Update Posted: January 4, 2017
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.
Collaborator:
ResMed Foundation
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: November 1, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Non Alcoholic Fatty Liver Disease
Obstructive Sleep Apnea
Intervention: Device: CPAP (ResMed S9 autoset CPAP)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
212 subjects screened; 166 subjects were excluded. 40 were included. 39 started in the protocol. 8 patients dropped out. Liver MRI completed in 27 subjects. 12 patients were excluded after liver MRI; 14 subjects had sleep studies. 5 patients did not proceed to the CPAP trial. 9 patients were randomized.

Reporting Groups
  Description
Deferred CPAP

Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.

Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.

CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study.

CPAP

Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the "auto mode" so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.

Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.


Participant Flow:   Overall Study
    Deferred CPAP   CPAP
STARTED   4   5 
COMPLETED   4   4 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Deferred CPAP

Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.

Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.

CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study.

CPAP

Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the "auto mode" so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.

Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.

Total Total of all reporting groups

Baseline Measures
   Deferred CPAP   CPAP   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   5   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (3.74)   42.8  (16.63)   49.56  (14.73) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  50.0%      2  40.0%      4  44.4% 
Male      2  50.0%      3  60.0%      5  55.6% 
Region of Enrollment 
[Units: Participants]
     
United States   4   5   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cross Sectional Analysis of NAFLD Versus Sleep Apnea Severity Indices (AHI)   [ Time Frame: 6 months ]

2.  Secondary:   Liver Values   [ Time Frame: 6 Months ]

3.  Secondary:   Analysis of Variance (ANOVA) in CPAP Versus No-CPAP Therapy on NAFLD   [ Time Frame: 6 months ]

4.  Secondary:   MRI Indices   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Seva Polotsky, M.D., PhD
Organization: Johns Hopkins University
phone: 410-550-6386
e-mail: vpolots1@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01482065     History of Changes
Other Study ID Numbers: NA_00048965
111481 ( Other Grant/Funding Number: ResMed Foundation )
First Submitted: November 15, 2011
First Posted: November 30, 2011
Results First Submitted: November 1, 2016
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017