Stroke Clinical Trial
— SCOUTS2Official title:
Maximizing Use of Continuous Positive Airway Pressure in Stroke Rehabilitation Patients With Obstructive Sleep Apnea
NCT number | NCT02809430 |
Other study ID # | 43428A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | July 2018 |
Verified date | November 2020 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence. In this study, the investigators enrolled eligible stroke patients undergoing inpatient rehabilitation (IPR) into an intensive CPAP adherence protocol (iCAP) with an aim to increase tolerance and adherence to auto-titrating CPAP (APAP).
Status | Completed |
Enrollment | 90 |
Est. completion date | July 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients admitted after acute ischemic or hemorrhagic stroke to one of two inpatient rehabilitation units Exclusion Criteria: - The investigators will exclude participants if: their stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding); they have active CPAP use, advanced chronic lung disease requiring supplemental oxygen, heart failure (NYHA class III or IV); or they needed a nasogastric feeding tube. |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
Khot S, Barnett H, Davis A, Siv J, Crane D, Kunze A, Li Lue D, Bunnell A, McCann B, Bombardier C, Longstreth WT Jr, Watson N, Billings M. Intensive Continuous Positive Airway Pressure Adherence Program During Stroke Rehabilitation. Stroke. 2019 Jul;50(7): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-month CPAP Adherence | Number of participants who continue CPAP after the run-in period who have acceptable adherence at 3 months, defined as using CPAP for an average of at least 4 hours a night on at least 70% of nights. | 3 months | |
Secondary | CPAP Tolerance | Number of eligible participants (those who continue CPAP after the run-in period) who are willing to continue CPAP treatment upon discharge from the rehabilitation unit. | Upon discharge from rehabilitation unit, typically at 14-21 days from CPAP initiation | |
Secondary | Change in the Cognitive Functional Independence Measure (FIM) Subscore | Change in the cognitive subscale of the Functional Independence Measure (FIM) over 3 months. The FIM, a disability scale measuring the burden of care associated with aspects of motor and cognitive function, includes a motor and cognitive component. The cognitive subscale includes 5 cognitive items: comprehension, expression, social interaction, problem solving and memory. Each of the 5 cognitive items are scored from 1 (complete dependence) to 7 (complete independence). The total scores from these 5 items for the cognitive subscale range from 5 to 35 with lower scores indicating greater functional disability. The 5 items from the cognitive subscale are combined with 13 items from the motor subscale yielding the 18 items of the total FIM with a minimum score of 18 and a maximum score of 126 with lower scores indicating greater functional disability. | Between admission to rehabilitation unit and between 3-4 months following enrollment | |
Secondary | Change in the Motor Functional Independence Measure (FIM) Subscore | Change in the motor subscale of the Functional Independence Measure (FIM) over 3 months. The FIM, a disability scale measuring the burden of care associated with aspects of motor and cognitive function, includes a motor and cognitive component. The motor subscale includes 13 motor items: eating, grooming, bathing, upper body dressing, lower body dressing, toileting, bladder management, bowel management, bed/chair transfer, toilet transfer, tub/shower transfer, walk/wheelchair locomotion and stair locomotion. Each of the 13 motor items are scored from 1 (complete dependence) to 7 (complete independence). The total scores from these 13 items for the motor subscale range from 13 to 91 with lower scores indicating greater functional disability. The 13 items from the motor subscale are combined with 5 items from the cognitive subscale yielding the 18 items of the total FIM with a minimum total score of 18 and a maximum score of 126 with lower scores indicating greater functional | Between admission to rehabilitation unit and between 3-4 months following enrollment | |
Secondary | Change in NIH Stroke Scale | The National Institutes of Health Stroke scale (NIHSS) is a 15-item scale used to rank the severity of ischemic stroke. The NIHSS includes measurements for levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scores range from 0 to 42 with higher scores indicating greater neurologic impairment. | NIHSS scores were obtained in-person on enrollment and at 90 ± 7 days from enrollment. |
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