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Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea (SASS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607893
First Posted: February 6, 2008
Last Update Posted: September 15, 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:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Reena Mehra, Case Western Reserve University
Results First Submitted: April 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Sleep Apnea Syndromes
Oxidative Stress
Cardiovascular Diseases
Interventions: Device: Continuous Positive Airway Pressure (CPAP)
Device: Sham CPAP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sham CPAP

Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.

Sham treatment: Participants will use the lower pressure CPAP every night for 8 weeks.

Treatment CPAP

Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.

Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.


Participant Flow:   Overall Study
    Sham CPAP   Treatment CPAP
STARTED [1]   77   76 
Completed Baseline Visit [2]   74   75 
Completed 8 Week Visit [3]   71   72 
Completed 12 Week Visit   0 [4]   29 [4] 
COMPLETED   71   72 
NOT COMPLETED   6   4 
Lost to Follow-up                4                0 
withdrew due to loss of interest                0                1 
Withdrew due to osteomyelitis surgery                0                1 
withdrew could not tolerate CPAP                0                1 
Declined to be treated                1                0 
Withdrew due to hypertensive urgency                1                1 
[1] Underwent Randomization
[2] Completed Baseline Visit
[3] Completed 8 Week Visit
[4] 12 Week Visit only offered to participants on actual CPAP Treatment



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Treatment CPAP Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
Sham CPAP Participants used the Sham CPAP every night for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Treatment CPAP   Sham CPAP   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   74   149 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.3  (11.7)   51.7  (11.8)   51.0  (11.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      34  45.3%      35  47.3%      69  46.3% 
Male      41  54.7%      39  52.7%      80  53.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian   37   41   78 
African American   36   31   67 
Other   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   75   74   149 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   F2-isoprostanes/Cr   [ Time Frame: Measured between baseline and after treatment ]

2.  Primary:   Myeloperoxidase   [ Time Frame: Measured between baseline and after treatment ]

3.  Secondary:   Mean Arterial BP, Evening   [ Time Frame: Measured between baseline and after treatment ]

4.  Secondary:   Pulse Wave Velocity, Evening   [ Time Frame: Measured between baseline and after treatment ]

5.  Secondary:   IL-6   [ Time Frame: Measured between baseline and after treatment ]

6.  Secondary:   Mean Arterial BP, Morning   [ Time Frame: Measured between baseline and after treatment ]

7.  Secondary:   sIL-6R   [ Time Frame: Measured between baseline and after treatment ]

8.  Secondary:   Pulse Wave Velocity, Morning   [ Time Frame: Measured between Months 2 and 3 of treatment ]

9.  Secondary:   Augmentation Index, Evening   [ Time Frame: Measured between Months 2 and 3 of treatment ]

10.  Secondary:   Augmentation Index, Morning   [ Time Frame: Measured between Months 2 and 3 of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Reena Mehra
Organization: Case Western Reserve University
phone: 216-445-1698
e-mail: mehrar@ccf.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Reena Mehra, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00607893     History of Changes
Other Study ID Numbers: 562
K23HL079114 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2008
First Posted: February 6, 2008
Results First Submitted: April 6, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017