Clinical trial NCT02551757: Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients
Official title: Randomized Trial of Continuous Positive Airway Pressure in Patients Undergoing Intensive Inpatient Rehabilitation After Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Sleep Apnea, Obstructive
Keywords: Rehabilitation
Continuous Positive Airway Pressure
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: 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.
timeFrame: 18 months
Secondary outcomes:
measure: Hours of CPAP Per Night
timeFrame: up to 28 days
measure: Median Change in the Functional Independence Measure (FIM) Between Admission and Discharge From the Rehabilitation Unit Comparing Active-CPAP Versus Sham-CPAP.
timeFrame: Baseline and discharge up to 28 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Associate Professor, Dept. Neurology
name: Sandeep Khot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khot SP, Davis AP, Crane DA, Tanzi PM, Lue DL, Claflin ES, Becker KJ, Longstreth WT Jr, Watson NF, Billings ME. Effect of Continuous Positive Airway Pressure on Stroke Rehabilitation: A Pilot Randomized Sham-Controlled Trial. J Clin Sleep Med. 2016 Jul 15;12(7):1019-26. doi: 10.5664/jcsm.5940.