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Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea (CATNAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00089752
First Posted: August 16, 2004
Last Update Posted: July 24, 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.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Respironics Sleep and Respiratory Foundation
Cephalon
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: September 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Lung Diseases
Sleep Apnea Syndromes
Hypertension
Interventions: Device: Continuous Positive Airway Pressure (CPAP) Treatment
Device: Sham CPAP device - CPAP device with pressure delivered <1 cm H20

  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
Participants were recruited from the sleep disorders clinic from each of the 5 participating centers. Potential participants were approached by study staff at each site once their medical record indicated that they may be candidates for the study. Recruitment commenced 1-11-05 and ended 4-18-2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active CPAP Continuous positive pressure device that delivers therapeutic positive airway pressure to maintain airway patency worn continuously for each night of treatment.
Sham CPAP A device that looks and sounds like an active continuous positive pressure device (CPAP) that delivers ineffective pressure, i.e.,less than 1 cm H20 pressure compared to greater than 5 cm H20 for active treatment. Like active CPAP treatment it is worn every night.

Participant Flow:   Overall Study
    Active CPAP   Sham CPAP
STARTED   141   140 
COMPLETED   121   118 
NOT COMPLETED   20   22 



  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.
No text entered.

Reporting Groups
  Description
Active CPAP CPAP device
Sham CPAP Sham CPAP device
Total Total of all reporting groups

Baseline Measures
   Active CPAP   Sham CPAP   Total 
Overall Participants Analyzed 
[Units: Participants]
 121   118   239 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      116  95.9%      112  94.9%      228  95.4% 
>=65 years      5   4.1%      6   5.1%      11   4.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      55  45.5%      44  37.3%      99  41.4% 
Male      66  54.5%      74  62.7%      140  58.6% 
Region of Enrollment 
[Units: Participants]
     
United States   68   68   136 
Canada   53   50   103 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment   [ Time Frame: 8 weeks ]

2.  Secondary:   Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale   [ Time Frame: Measured at Baseline and Week 8 of treatment in ITT sample ]

3.  Secondary:   Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment   [ Time Frame: Measured at Baseline and Week 8 treatment in the ITT sample ]

4.  Secondary:   Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States   [ Time Frame: Measured at Baseline and Week 8 treatment in the ITT sample ]

5.  Secondary:   Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test   [ Time Frame: Baseline and 8 weeks of treatment in the ITT sample ]

6.  Secondary:   Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical   [ Time Frame: Baseline and Week 8 of treatment in ITT sample. ]

7.  Secondary:   Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component   [ Time Frame: Baseline and after 8 weeks of treatment in ITT sample ]


  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
Post-randomization adverse events are summarized by treatment arm & body system.The CTC-AE (Publish Date December 12, 2003) was utilized for coding verbatim (raw) adverse event data with a MedDRA code, Body System, AE/Supraordinate term & Grade.


  More Information
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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:  
Name/Title: Terri E. Weaver, PhD, RN, FAAN
Organization: University of Pennsylvania School of Nursing
phone: 215-898-2992
e-mail: tew@nursing.upenn.edu


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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00089752     History of Changes
Other Study ID Numbers: 163
R01HL076101 ( U.S. NIH Grant/Contract )
First Submitted: August 12, 2004
First Posted: August 16, 2004
Results First Submitted: September 18, 2009
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017