Telecommunications System in Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00232544
First received: September 30, 2005
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: November 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Sleep Apnea, Obstructive
Intervention: Device: Telecommunications system

  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
TLC-CPAP A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
TLC-Control A TLC system for providing general health education

Participant Flow:   Overall Study
    TLC-CPAP     TLC-Control  
STARTED     124     126  
COMPLETED     104     111  
NOT COMPLETED     20     15  
Lost to Follow-up                 20                 15  



  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
TLC-CPAP A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
TLC-Control A TLC system for providing general health education
Total Total of all reporting groups

Baseline Measures
    TLC-CPAP     TLC-Control     Total  
Number of Participants  
[units: participants]
  124     126     250  
Age  
[units: years]
Median ( Inter-Quartile Range )
  56  
  ( 48 to 63 )  
  54  
  ( 45 to 62 )  
  55  
  ( 46 to 63 )  
Gender  
[units: participants]
     
Female     24     21     45  
Male     100     105     205  
Region of Enrollment  
[units: participants]
     
United States     124     126     250  



  Outcome Measures
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1.  Primary:   Objective CPAP Use   [ Time Frame: 12 months ]

2.  Secondary:   Daytime Vigilance   [ Time Frame: 12 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. David Sparrow
Organization: VA Boston Healthcare System
phone: 857-364-6407
e-mail: david.sparrow@va.gov


No publications provided by Department of Veterans Affairs

Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00232544     History of Changes
Other Study ID Numbers: IIR 02-230
Study First Received: September 30, 2005
Results First Received: November 4, 2013
Last Updated: April 15, 2014
Health Authority: United States: Federal Government