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

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ClinicalTrials.gov Identifier: NCT00880165
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Leonard Davis Institute of Health Economics
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Obstructive Sleep Apnea
Intervention Device: Continuous positive airway pressure apparatus
Enrollment 296

Recruitment Details  
Pre-assignment Details  
Arm/Group Title In-laboratory Testing Home Unattended Testing
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 148 148
Completed 86 98
Not Completed 62 50
Reason Not Completed
Withdrawal by Subject             27             23
Not diagnosed with OSA             14             8
Required BIPAP or oxygen treatment             12             4
Lost to follow             9             15
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 148 148 296
Hide Baseline Analysis Population Description
Veterans referred to the participating sleep centers for evaluation of obstructive sleep apnea
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 148 participants 296 participants
51.8  (10.4) 55.1  (10.3) 53.2  (10.4)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 148 participants 296 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
137
  92.6%
135
  91.2%
272
  91.9%
>=65 years
11
   7.4%
13
   8.8%
24
   8.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 148 participants 296 participants
Female
10
   6.8%
13
   8.8%
23
   7.8%
Male
138
  93.2%
135
  91.2%
273
  92.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 148 participants 148 participants 296 participants
148 148 296
Functional Outcome of Sleep Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 148 participants 148 participants 296 participants
14.7  (2.9) 15.0  (3.2) 14.9  (3.0)
[1]
Measure Description: 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.
1.Primary Outcome
Title Cost
Hide Description VA sleep-study and treatment medical service use will be derived from the case report form; and costed out using VA acquisition costs. Other medical service use will be derived from VA administrative records. Non-VA medical service use will be derived from patient interview and will be costed out using federal reimbursement schedules. Costs will be stratified by whether or not they are related to the diagnosis and treatment of OSA.Cost and preferences are assessed for each entire arm.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 110 113
Measure Type: Number
Unit of Measure: dollars
4621 4057
2.Secondary Outcome
Title Functional Outcome of Sleep Questionnaire
Hide Description Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 110 113
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.85  (2.46) 1.74  (2.81)
3.Secondary Outcome
Title Continuous Positive Airway Pressure Adherence
Hide Description Mean daily hours of use of continuous positive airway pressure over the 3 month intervention
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 110 113
Mean (Standard Deviation)
Unit of Measure: hours per day
2.92  (2.32) 3.49  (2.45)
Time Frame Adverse events were collected every 3 months for the entire observation period. Collection of adverse events occurred over 2.25 years in the first enrolled participant and over 3 months in the last enrolled participant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/148 (0.00%)   0/148 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/148 (0.00%)   0/148 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Samuel T. Kuna, MD
Organization: Philadelphia VA Medical Center
Phone: 215-823-4400
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00880165     History of Changes
Other Study ID Numbers: IIR 04-021
First Submitted: April 10, 2009
First Posted: April 13, 2009
Results First Submitted: January 8, 2014
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014