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Telecommunications System in Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00232544
First received: September 30, 2005
Last updated: April 6, 2015
Last verified: October 2013
Results First Received: November 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 
Overall Participants Analyzed 
[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


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

Responsible Party: VA Office of Research and Development
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 6, 2015