We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telecommunications System in Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232544
First Posted: October 4, 2005
Last Update Posted: April 24, 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):
VA Office of Research and Development
Results First Submitted: November 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Condition: Sleep Apnea, Obstructive
Intervention: Device: Telecommunications system

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
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
  Hide Baseline Characteristics

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
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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
First Submitted: September 30, 2005
First Posted: October 4, 2005
Results First Submitted: November 4, 2013
Results First Posted: February 17, 2014
Last Update Posted: April 24, 2015