Hypertension, Obstructive Sleep Apnea, Stroke, Transient Ischemic Attack
Conditions
Keywords
sleep apnea, hypertension, brain ischemia
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stroke or Transient Ischemic Attack Hypertension
Exclusion criteria
* Prior diagnosis of sleep apnea or other sleep disorder * Life expectancy \< 6 months or Hospice * Non-English speaker * Unable/unwilling to use mask * Inability to give informed consent * Oxygen dependent COPD * Chronic renal failure with dialysis * Active Suicidal Ideation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Apnea Diagnosis Rate | The entire study period (baseline and up to one-year) | The number of patients with a diagnosis of sleep apnea |
| Hypertension Control | One year | Medication-Adjusted Systolic Blood Pressure |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Apnea Treatment Rate | One year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention | 110 |
| Control | 115 |
| Total | 225 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 10.4 | 70.2 years STANDARD_DEVIATION 10.1 | 70 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 109 Participants | 110 Participants | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 110 | 30 / 115 |
| serious Total, serious adverse events | 5 / 110 | 2 / 115 |
Outcome results
Primary
Hypertension Control
Medication-Adjusted Systolic Blood Pressure
Time frame: One year
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Hypertension Control | 157.4 mm Hg | Standard Deviation 25 |
| Control | Hypertension Control | 161.6 mm Hg | Standard Deviation 24.3 |
Primary
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)
Population: The intervention patients had polysomnography at baseline (n=102) whereas control patients either had polysomnography as part of usual care (n=7) or at the end of the study as part of the study protocol (n=85). The n=7 patients who had polysomnography as part of usual care were included in the analysis for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Sleep Apnea Diagnosis Rate | 58 participants |
| Control | Sleep Apnea Diagnosis Rate | 5 participants |
Secondary
Sleep Apnea Treatment Rate
Time frame: One year
Population: Among the 58 intervention patients with a diagnosis of sleep apnea, CPAP data were available for 57. Among the 7 control patients who received polysomnography as part of usual care, 5 had sleep apnea: CPAP data were available for 4 patients (2 did not receive any CPAP and 2 had CPAP therapy), the data card was unavailable for 1 patient.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Sleep Apnea Treatment Rate | 22 participants |
| Control | Sleep Apnea Treatment Rate | 0 participants |