A Phase 2/3 interventional study of CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA) in Obstructive Sleep Apnea, Stroke and Transient Ischemic Attack, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by VA Office of Research and Development · Phase 2/3, Interventional, and Treatment
Sleep apnea is common among Veterans with cerebrovascular disease (stroke or transient ischemic attack [TIA]), leads to hypertension, and is associated with recurrent stroke and death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few Veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.
The project sought to evaluate whether a diagnostic and therapeutic intervention strategy among Veterans with cerebrovascular disease and hypertension using unattended polysomnography and auto-titrating CPAP with a targeted adherence evaluation and educational protocol resulted in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and improved blood pressure control.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 225 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Stroke or Transient Ischemic Attack Hypertension
Exclusion Criteria:
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.
Sleep Apnea Diagnosis Rate
The number of patients with a diagnosis of sleep apnea
Time frame: The entire study period (baseline and up to one-year)
Hypertension Control
Medication-Adjusted Systolic Blood Pressure
Time frame: One year
Sleep Apnea Treatment Rate
Time frame: One year
| Milestone | Intervention | Control |
|---|---|---|
| Started | 110 | 115 |
| Completed | 92 | 109 |
| Not completed | 18 | 6 |
The number of patients with a diagnosis of sleep apnea
| participants | Intervention | Control |
|---|---|---|
| Sleep Apnea Diagnosis Rate | 58 | 5 |
Medication-Adjusted Systolic Blood Pressure
| mm Hg | Intervention | Control |
|---|---|---|
| Hypertension Control | 157.4 ± 25 | 161.6 ± 24.3 |
| participants | Intervention | Control |
|---|---|---|
| Sleep Apnea Treatment Rate | 22 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | 5/110 (4.5%) | 22/110 (20%) |
| Control | — | 2/115 (1.7%) | 30/115 (26.1%) |
| Event | Intervention | Control |
|---|---|---|
| Congestive heart failure (CHF)Cardiac disorders | 3/110 | 0/115 |
| Transient ischemic attack (TIA)Nervous system disorders | 1/110 | 1/115 |
| DEATHGeneral disorders | 1/110 | 0/115 |
| strokeNervous system disorders | 0/110 | 1/115 |
| Acute myocardial infarction (AMI)Cardiac disorders | 0/110 | 0/115 |
| Event | Intervention | Control |
|---|---|---|
| FallsGeneral disorders | 22/110 | 30/115 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 69.7 ± 10.4 | 70.2 ± 10.1 | 70 ± 10 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 1 | 5 | 6 |
| Male | 109 | 110 | 219 |
Plan to share: Undecided
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development