Cost Effectiveness of Ambulatory Management for Veterans With Sleep Apnea (VSATT)

This study has been completed.
Sponsor:
Collaborator:
Leonard Davis Institute of Health Economics
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00880165
First received: April 10, 2009
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: January 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Obstructive Sleep Apnea
Intervention: Device: Continuous positive airway pressure apparatus

  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
No text entered.

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
In-laboratory Testing

In-laboratory testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment.

Home Unattended Testing

Home unattended testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment.


Participant Flow:   Overall Study
    In-laboratory Testing     Home Unattended Testing  
STARTED     148     148  
COMPLETED     86     98  
NOT COMPLETED     62     50  
Withdrawal by Subject                 27                 23  
Not diagnosed with OSA                 14                 8  
Required BIPAP or oxygen treatment                 12                 4  
Lost to follow                 9                 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.
Veterans referred to the participating sleep centers for evaluation of obstructive sleep apnea

Reporting Groups
  Description
Arm 1

In-laboratory testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Arm 2

Home unattended testing

Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  148     148     296  
Age  
[units: years]
Mean ± Standard Deviation
  51.8  ± 10.4     55.1  ± 10.3     53.2  ± 10.4  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     137     135     272  
>=65 years     11     13     24  
Gender  
[units: participants]
     
Female     10     13     23  
Male     138     135     273  
Region of Enrollment  
[units: participants]
     
United States     148     148     296  
Functional Outcome of Sleep Questionnaire [1]
[units: units on a scale]
Mean ± Standard Deviation
  14.7  ± 2.9     15.0  ± 3.2     14.9  ± 3.0  
[1] Self-administered validated questionnaire assessing functional outcomes in patients with obstructive sleep apnea. The FOSQ total score range is from 1 to 20 with higher scores indicating better functional outcome. The FOSQ has 5 subscale scores: activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, The range of subscale scores is from 1 to 4 with higher scores indicating better function. The total score is calculated as the mean of the subscales multiplied by 5.



  Outcome Measures
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1.  Primary:   Cost   [ Time Frame: Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years. ]

2.  Secondary:   Functional Outcome of Sleep Questionnaire   [ Time Frame: 3 months ]

3.  Secondary:   Continuous Positive Airway Pressure Adherence   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Samuel T. Kuna, MD
Organization: Philadelphia VA Medical Center
phone: 215-823-4400
e-mail: Samuel.Kuna@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00880165     History of Changes
Other Study ID Numbers: IIR 04-021
Study First Received: April 10, 2009
Results First Received: January 8, 2014
Last Updated: March 18, 2014
Health Authority: United States: Federal Government