Clinical trial NCT02809430: Stroke and CPAP Outcome Study 2
Official title: Maximizing Use of Continuous Positive Airway Pressure in Stroke Rehabilitation Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Stroke
Patient Adherence
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The SCOUTS (Stroke and CPAP Outcome Study 2) was a single-arm, open-label study performed at 2 IPR units of the University of Washington. Eligible stroke patients undergoing IPR were provided an intensive CPAP adherence protocol (iCAP) to increase tolerance and adherence to auto-titrating CPAP (APAP). The iCAP included patient education and encouragement, device adjustments, close monitoring of adherence and a 3-night run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP tolerance-- defined as participant willingness to continue APAP during IPR and over the 3-month treatment period. If both criteria were met, APAP treatment with iCAP continued during the rehabilitation stay and over a 3-month period. The goal of the intervention was to achieve 50% of subjects meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period. The investigators evaluated if demographic, co-morbid or stroke-specific factors predicted APAP adherence and assessed the relationship between APAP adherence and neurological recovery from stroke.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-month CPAP Adherence
timeFrame: 3 months
Secondary outcomes:
measure: CPAP Tolerance
timeFrame: Upon discharge from rehabilitation unit, typically at 14-21 days from CPAP initiation
measure: Change in the Cognitive Functional Independence Measure (FIM) Subscore
timeFrame: Between admission to rehabilitation unit and between 3-4 months following enrollment
measure: Change in the Motor Functional Independence Measure (FIM) Subscore
timeFrame: Between admission to rehabilitation unit and between 3-4 months following enrollment
measure: Change in NIH Stroke Scale
timeFrame: NIHSS scores were obtained in-person on enrollment and at 90 ± 7 days from enrollment.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Sandeep Khot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):1895-1897. doi: 10.1161/STROKEAHA.119.024795. Epub 2019 May 20.
citation: Khot SP, Barnett HM, Davis AP, Byun E, McCann BS, Bombardier CH, Rappisi K, Longstreth WT Jr, Billings ME, Brown DL, Garrison MM. Novel and modifiable factors associated with adherence to continuous positive airway pressure therapy initiated during stroke rehabilitation: An exploratory analysis of a prospective cohort study. Sleep Med. 2022 Sep;97:43-46. doi: 10.1016/j.sleep.2022.05.013. Epub 2022 May 26.