Obstructive Sleep ApneaVSATTNCT00880165
Cost Effectiveness of Ambulatory Management for Veterans With Sleep Apnea
A study testing Continuous positive airway pressure apparatus in people with Obstructive Sleep Apnea, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
This research study is comparing home and in-laboratory testing of veterans with suspected obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home testing will be equally effective in improving quality of life but have lower cost than in-lab testing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals willing to participate must meet the following eligibility criteria prior to enrollment:
- Patients referred for a sleep evaluation for suspected sleep apnea.
- Age 18 years or older
- Living within 90 miles of the Sleep Center.
Who cannot join
- Individuals will be excluded from the study for the following reasons:
- Unable or unwilling to provide informed written consent.
- Lack of telephone access or inability to return for follow-up testing.
- A history of prior sleep evaluations, OSA treatment, or sleep disorder in addition to OSA.
- A clinically unstable chronic medical condition as defined by a new diagnosis or change in medical management in the previous 3 months of cardiac disease, thyroid disease, diabetes, depression or psychosis, cirrhosis, or recently diagnosed cancer.
- Individuals already on long term oxygen therapy or requiring bilevel positive airway pressure.
Show all 9Show fewer
- Individuals with rotating shift work or irregular work schedules over the last 6 months.
- Suspected or confirmed to be pregnant. A pregnancy test will be performed using the urine sample obtained at the initial visit.
- Inability to complete the Assessment Battery - e.g. less than a 5th grade reading level
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Leonard Davis Institute of Health Economics
Philadelphia, Pennsylvania, 19104-6128
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Cost Effective Strategy to Evaluate Veterans With Sleep Apnea
This research study is comparing home and in-laboratory testing of veterans with suspected obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home testing will be equally effective in improving quality of life but have lower cost than in-lab testing. These findings will allow veterans to have greater access to diagnosis and treatment of their sleep apnea.
Read the detailed description
Objective: The overall goal of the project is to improve access to care for veterans with suspected obstructive sleep apnea (OSA), a breathing disorder during sleep characterized by repetitive closure of the pharyngeal airway. Portable monitors are commercially available to diagnose participants with suspected OSA and establish the continuous positive airway pressure (CPAP) setting needed for treatment. Their application to home testing is not widely accepted because it is not known whether home testing, when compared to conventional in-lab polysomnograms, is cost effective and produces similar outcomes with regard to participant adherence to CPAP treatment and improvements in functional impairment. The specific goals of the proposed research are to address these barriers by comparing the functional impact, cost, and cost-effectiveness of evaluating veterans with suspected OSA using home versus in-lab testing.
Research Design: In this prospective randomized control trial of equivalency, participants referred to the Philadelphia and Pittsburgh VA Medical Centers for evaluation for OSA will be randomized to either exclusively in-lab or home testing following baseline assessment.
Methodology: In-lab polysomnograms will be performed to diagnose OSA and titrate the pressure setting for subsequent CPAP therapy. Self-administered home testing will consist of an overnight unattended sleep study followed by a 1-week autoCPAP titration trial. Objectively assessed CPAP adherence and its consequent effects on subjective and objective daytime sleepiness, disease specific and general functional impairment, and participant preference will be obtained at 1- and 3-months after starting CPAP treatment and 3-monthly thereafter to the end of study follow-up. Medical service use and cost will be collected for the entire observation period.
Aim 1 will determine if participants with suspected OSA who receive home testing have the same adherence to subsequent CPAP treatment and the same functional outcomes as participants receiving in-lab testing. Primary outcome measures will be 1) objectively measured adherence to CPAP treatment and 2) the global score on the Functional Outcomes of Sleep Questionnaire (FOSQ) to assess the consequent effects of adherence on disease specific functional impairment. Secondary functional outcome measures will assess subjective (Epworth Sleepiness Scale) and objective (Psychomotor Vigilance Test) daytime sleepiness, and general quality of life (SF-12). Hypothesis 1: Despite differences between in-lab versus home testing in terms of technology, time participants interact with health care professionals, and environment, there is no clinically significant decline in mean CPAP adherence and no clinically significant reduction in functional outcomes in participants receiving home versus in-lab testing.
Aim 2 will compare the differences in cost and quality-adjusted life years saved (QALYS) between home versus in-lab testing to estimate a cost-effectiveness ratio. Participant preference will be assessed with the EuroQol (EQ-5D) and Health Utilities Index 2 (HUI). Hypothesis 2a: Average total health-care delivery cost is lower for veterans receiving home testing relative to those receiving in-lab testing. Hypothesis 2b: Because we believe that at-home testing will have lower costs and equivalent outcomes, we will be 90% confident that the cost per QALY ratio comparing at-home testing with in-lab testing will be less than $100,000.
Clinical Relationship: We need to determine the most cost effective way to diagnose veterans with OSA and initiate them on CPAP treatment. If the results show that home testing produces clinical outcomes that are not significantly clinically inferior and similar or reduced costs compared with in-lab testing, decision makers can be confident that home monitors can be used to diagnose and treat OSA and that improving veterans' access to care for OSA need not require construction of additional, costly sleep labs.
Findings: We anticipate that the results of Aim 1 will demonstrate that participants receiving in-lab versus home testing have similar clinical outcomes. We further anticipate that Aim 2 will demonstrate that home testing is more cost effective than in-lab testing. If confirmed, these findings will lead to wide acceptance of home portable monitor testing and increase veteran access to care.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous positive airway pressure apparatus
- Keywords
- Polysomnogram, Continuous positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure apparatusDevice
Also called CPAP
Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | In-laboratory testing followed by continuous positive airway pressure treatment Receives: Device: Continuous positive airway pressure apparatus |
| Arm 2 | Active comparator | Home unattended testing followed by continuous positive airway pressure treatment Receives: Device: Continuous positive airway pressure apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost
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.
Measured: 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.
Secondary outcomes (2)
Functional Outcome of Sleep Questionnaire
Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment
Measured: 3 months
Continuous Positive Airway Pressure Adherence
Mean daily hours of use of continuous positive airway pressure over the 3 month intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startNov 2006
- Primary completionJul 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Samuel T. Kuna, MD, Principal investigator, VA Medical Center, Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880165
- Sponsor's protocol ID
- IIR 04-021
- Acronym
- VSATT
- Status last verified
- Mar 2014
- First submitted
- 10 Apr 2009
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sunwoo B, Kuna ST. Ambulatory management of patients with sleep apnea: is there a place for portable monitor testing? Clin Chest Med. 2010 Jun;31(2):299-308. doi: 10.1016/j.ccm.2010.02.003.
PubMed 20488288Kuna ST, Gurubhagavatula I, Maislin G, Hin S, Hartwig KC, McCloskey S, Hachadoorian R, Hurley S, Gupta R, Staley B, Atwood CW. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. 2011 May 1;183(9):1238-44. doi: 10.1164/rccm.201011-1770OC. Epub 2011 Jan 21.
PubMed 21471093
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effective Strategy to Evaluate Veterans With Sleep Apnea
- ClinicalTrials.gov ID
- NCT00880165
- Acronym / sponsor ID
- VSATT / IIR 04-021
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Polysomnogram, Continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Pennsylvania
- Study start
- Nov 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is comparing home and in-laboratory testing of veterans with suspected obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home testing will be equally effective in improving quality of life but have lower cost than in-lab testing. These findings will allow veterans to have greater access to diagnosis and treatment of their sleep apnea.
Detailed description
Objective: The overall goal of the project is to improve access to care for veterans with suspected obstructive sleep apnea (OSA), a breathing disorder during sleep characterized by repetitive closure of the pharyngeal airway. Portable monitors are commercially available to diagnose participants with suspected OSA and establish the continuous positive airway pressure (CPAP) setting needed for treatment. Their application to home testing is not widely accepted because it is not known whether home testing, when compared to conventional in-lab polysomnograms, is cost effective and produces similar outcomes with regard to participant adherence to CPAP treatment and improvements in functional impairment. The specific goals of the proposed research are to address these barriers by comparing the functional impact, cost, and cost-effectiveness of evaluating veterans with suspected OSA using home versus in-lab testing.
Research Design: In this prospective randomized control trial of equivalency, participants referred to the Philadelphia and Pittsburgh VA Medical Centers for evaluation for OSA will be randomized to either exclusively in-lab or home testing following baseline assessment.
Methodology: In-lab polysomnograms will be performed to diagnose OSA and titrate the pressure setting for subsequent CPAP therapy. Self-administered home testing will consist of an overnight unattended sleep study followed by a 1-week autoCPAP titration trial. Objectively assessed CPAP adherence and its consequent effects on subjective and objective daytime sleepiness, disease specific and general functional impairment, and participant preference will be obtained at 1- and 3-months after starting CPAP treatment and 3-monthly thereafter to the end of study follow-up. Medical service use and cost will be collected for the entire observation period.
Aim 1 will determine if participants with suspected OSA who receive home testing have the same adherence to subsequent CPAP treatment and the same functional outcomes as participants receiving in-lab testing. Primary outcome measures will be 1) objectively measured adherence to CPAP treatment and 2) the global score on the Functional Outcomes of Sleep Questionnaire (FOSQ) to assess the consequent effects of adherence on disease specific functional impairment. Secondary functional outcome measures will assess subjective (Epworth Sleepiness Scale) and objective (Psychomotor Vigilance Test) daytime sleepiness, and general quality of life (SF-12). Hypothesis 1: Despite differences between in-lab versus home testing in terms of technology, time participants interact with health care professionals, and environment, there is no clinically significant decline in mean CPAP adherence and no clinically significant reduction in functional outcomes in participants receiving home versus in-lab testing.
Aim 2 will compare the differences in cost and quality-adjusted life years saved (QALYS) between home versus in-lab testing to estimate a cost-effectiveness ratio. Participant preference will be assessed with the EuroQol (EQ-5D) and Health Utilities Index 2 (HUI). Hypothesis 2a: Average total health-care delivery cost is lower for veterans receiving home testing relative to those receiving in-lab testing. Hypothesis 2b: Because we believe that at-home testing will have lower costs and equivalent outcomes, we will be 90% confident that the cost per QALY ratio comparing at-home testing with in-lab testing will be less than $100,000.
Clinical Relationship: We need to determine the most cost effective way to diagnose veterans with OSA and initiate them on CPAP treatment. If the results show that home testing produces clinical outcomes that are not significantly clinically inferior and similar or reduced costs compared with in-lab testing, decision makers can be confident that home monitors can be used to diagnose and treat OSA and that improving veterans' access to care for OSA need not require construction of additional, costly sleep labs.
Findings: We anticipate that the results of Aim 1 will demonstrate that participants receiving in-lab versus home testing have similar clinical outcomes. We further anticipate that Aim 2 will demonstrate that home testing is more cost effective than in-lab testing. If confirmed, these findings will lead to wide acceptance of home portable monitor testing and increase veteran access to care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: Continuous positive airway pressure apparatusIn-laboratory testing followed by continuous positive airway pressure treatment |
| Arm 2 | Active comparator | Device: Continuous positive airway pressure apparatusHome unattended testing followed by continuous positive airway pressure treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals willing to participate must meet the following eligibility criteria prior to enrollment:
- Patients referred for a sleep evaluation for suspected sleep apnea.
- Age 18 years or older
- Living within 90 miles of the Sleep Center.
Key exclusion criteria (9 listed)
- Unable or unwilling to provide informed written consent.
- Lack of telephone access or inability to return for follow-up testing.
- A history of prior sleep evaluations, OSA treatment, or sleep disorder in addition to OSA.
- A clinically unstable chronic medical condition as defined by a new diagnosis or change in medical management in the previous 3 months of cardiac disease, thyroid disease, diabetes, depression or psychosis, cirrhosis, or recently diagnosed cancer.
- Individuals already on long term oxygen therapy or requiring bilevel positive airway pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressure apparatusAlso: CPAPVeterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure. | Device | Arm 1, Arm 2 |
Primary outcome
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.
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.
2 secondary outcomes
Functional Outcome of Sleep Questionnaire
Time frame: 3 months
Continuous Positive Airway Pressure Adherence
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20488288Sunwoo B, Kuna ST. Ambulatory management of patients with sleep apnea: is there a place for portable monitor testing? Clin Chest Med. 2010 Jun;31(2):299-308. doi: 10.1016/j.ccm.2010.02.003.
- Results publication: PubMed 21471093Kuna ST, Gurubhagavatula I, Maislin G, Hin S, Hartwig KC, McCloskey S, Hachadoorian R, Hurley S, Gupta R, Staley B, Atwood CW. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. 2011 May 1;183(9):1238-44. doi: 10.1164/rccm.201011-1770OC. Epub 2011 Jan 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel T. Kuna, MD principal investigator
VA Medical Center, Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure apparatus in people with Obstructive Sleep Apnea, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880165, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.