Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01355419
First received: May 6, 2011
Last updated: April 27, 2015
Last verified: April 2015
Results First Received: 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  
Number of Participants  
[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


No publications provided


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
Study First Received: May 6, 2011
Results First Received: February 20, 2015
Last Updated: April 27, 2015
Health Authority: Belgium: Ethics Committee