Phase 2
N=40
Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients
Stroke · Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02551757 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Feasibility of Enrolling Eligible Stroke Patients Admitted to Inpatient Rehabilitation for an Acute Ischemic or Hemorrhagic Stroke Into a Pilot, Randomized Clinical Trial of Active Versus Sham CPAP. — 13; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Auto-titrating CPAP (Device); Sham-CPAP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Enrolling Eligible Stroke Patients Admitted to Inpatient Rehabilitation for an Acute Ischemic or Hemorrhagic Stroke Into a Pilot, Randomized Clinical Trial of Active Versus Sham CPAP. |
13; 17 | — |
| SECONDARY Hours of CPAP Per Night |
3.9; 3.6 | — |
| SECONDARY Median Change in the Functional Independence Measure (FIM) Between Admission and Discharge From the Rehabilitation Unit Comparing Active-CPAP Versus Sham-CPAP. |
34; 26 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02551757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.