Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Neurology, Pulmonary |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | July 2015 |
Randomized Trial of Continuous Positive Airway Pressure in Patients Undergoing Intensive Inpatient Rehabilitation After Acute Stroke
The purpose of this study is to assess the effect of continuous positive airway pressure
(CPAP) on functional outcome in patients with acute stroke, the investigators conducted a
sham-controlled, double-blind pilot trial during inpatient rehabilitation.
Patients with acute stroke were recruited and randomly assigned to auto-titrating or
sham-CPAP during their rehabilitation stay.
(CPAP) on functional outcome in patients with acute stroke, the investigators conducted a
sham-controlled, double-blind pilot trial during inpatient rehabilitation.
Patients with acute stroke were recruited and randomly assigned to auto-titrating or
sham-CPAP during their rehabilitation stay.
All acute stroke patients admitted to the inpatient rehabilitation service at the University
of Washington were invited to participate in the study. Given the high prevalence of
obstructive sleep apnea (OSA) in this population, no screen for OSA was performed. Enrolled
patients were assigned randomly to active-CPAP with auto-titrating pressures or to sham-CPAP
with an otherwise identical device but with pressures ≤ 1 cm water. Subjects used active or
sham-CPAP for the duration of inpatient rehabilitation, but no longer than 28 days. CPAP
compliance was assessed by memory card that recorded mask-on time. Other information on
download, such as apnea-hypopnea index, was only available on active-CPAP and not assessed
by investigators in real time. In this study, the investigators defined tolerance as any
continued use of CPAP at night and adherence as mean hours of CPAP use per night in those
who were CPAP tolerant.
of Washington were invited to participate in the study. Given the high prevalence of
obstructive sleep apnea (OSA) in this population, no screen for OSA was performed. Enrolled
patients were assigned randomly to active-CPAP with auto-titrating pressures or to sham-CPAP
with an otherwise identical device but with pressures ≤ 1 cm water. Subjects used active or
sham-CPAP for the duration of inpatient rehabilitation, but no longer than 28 days. CPAP
compliance was assessed by memory card that recorded mask-on time. Other information on
download, such as apnea-hypopnea index, was only available on active-CPAP and not assessed
by investigators in real time. In this study, the investigators defined tolerance as any
continued use of CPAP at night and adherence as mean hours of CPAP use per night in those
who were CPAP tolerant.
Inclusion Criteria:
- greater than 18 years of age
- admitted to an inpatient rehabilitation unit at the University of Washington
- head CT or brain MRI demonstrating an ischemic or hemorrhagic stroke
- enrolled in another research study
Exclusion Criteria:
- stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular
malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding)
- history of CPAP use, advanced chronic lung disease requiring supplemental oxygen,
heart failure (NYHA class III or IV)
- require a nasogastric feeding tube.
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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