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Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355419
First Posted: May 18, 2011
Last Update Posted: May 12, 2015
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.
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
Results First Submitted: February 20, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Obstructive Sleep Apnea

  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
Obstructive Sleep Apnea, CPAP moderate to severe obstructive sleep apnea requiring CPAP therapy

Participant Flow:   Overall Study
    Obstructive Sleep Apnea, CPAP
STARTED   150 
COMPLETED   142 
NOT COMPLETED   8 



  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
Obstructive Sleep Apnea, CPAP moderate to severe obstructive sleep apnea requiring CPAP therapy

Baseline Measures
   Obstructive Sleep Apnea, CPAP 
Overall Participants Analyzed 
[Units: Participants]
 150 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (10) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   150 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   60 
Male   90 
Region of Enrollment 
[Units: Participants]
 
Belgium   150 


  Outcome Measures
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1.  Primary:   Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients   [ Time Frame: baseline and at 3 months ]

2.  Secondary:   Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients   [ Time Frame: baseline and at 3 months ]


  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: Dr Marie Bruyneel
Organization: CHU St Pierre
phone: 00325354219
e-mail: Marie_BRUYNEEL@stpierre-bru.be



Responsible Party: Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01355419     History of Changes
Other Study ID Numbers: AK/10-07-45/3912
First Submitted: May 6, 2011
First Posted: May 18, 2011
Results First Submitted: February 20, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015