Trial Outcomes & Findings for Cost Effectiveness of Ambulatory Management for Veterans With Sleep Apnea (NCT NCT00880165)
NCT ID: NCT00880165
Last Updated: 2014-04-21
Results Overview
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.
COMPLETED
NA
296 participants
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.
2014-04-21
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
148
|
|
Overall Study
COMPLETED
|
86
|
98
|
|
Overall Study
NOT COMPLETED
|
62
|
50
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
27
|
23
|
|
Overall Study
Not diagnosed with OSA
|
14
|
8
|
|
Overall Study
Required BIPAP or oxygen treatment
|
12
|
4
|
|
Overall Study
Lost to follow
|
9
|
15
|
Baseline Characteristics
Cost Effectiveness of Ambulatory Management for Veterans With Sleep Apnea
Baseline characteristics by cohort
| Measure |
Arm 1
n=148 Participants
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
n=148 Participants
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
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
137 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148 participants
n=5 Participants
|
148 participants
n=7 Participants
|
296 participants
n=5 Participants
|
|
Functional Outcome of Sleep Questionnaire
|
14.7 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
14.9 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Arm 1
n=110 Participants
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
n=113 Participants
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.
|
|---|---|---|
|
Cost
|
4621 dollars
2
|
4057 dollars
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment
Outcome measures
| Measure |
Arm 1
n=110 Participants
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
n=113 Participants
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.
|
|---|---|---|
|
Functional Outcome of Sleep Questionnaire
|
1.85 units on a scale
Standard Deviation 2.46
|
1.74 units on a scale
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
Mean daily hours of use of continuous positive airway pressure over the 3 month intervention
Outcome measures
| Measure |
Arm 1
n=110 Participants
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
n=113 Participants
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.
|
|---|---|---|
|
Continuous Positive Airway Pressure Adherence
|
2.92 hours per day
Standard Deviation 2.32
|
3.49 hours per day
Standard Deviation 2.45
|
Adverse Events
Arm 1
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place