Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients (SCOUTS)
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|ClinicalTrials.gov Identifier: NCT02551757|
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Sleep Apnea, Obstructive||Device: Auto-titrating CPAP Device: Sham-CPAP||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Trial of Continuous Positive Airway Pressure in Patients Undergoing Intensive Inpatient Rehabilitation After Acute Stroke|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||July 2015|
Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5.
Device: Auto-titrating CPAP
Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with active-CPAP included patient education, desensitization of CPAP through brief periods of daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing CPAP maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP.
Sham Comparator: Sham-CPAP
The sham-CPAP device in our study was designed to entail no risks beyond those with standard CPAP and provide a high level of blinding. The sham-CPAP device is an auto-titrating CPAP with an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification creates a larger than standard air leak that serves to prevent any chances of carbon dioxide rebreathing and delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water. The elbow modification is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel. The elbow modification could only be used on standard nasal masks; consequently full facemasks and nasal pillows were excluded for patients in both active and sham-CPAP.
Sham-CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included patient education, desensitization of CPAP through brief periods of daytime use and adjustments of humidity and mask, including addition of a chin strap.
- 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. [ Time Frame: 18 months ]Number of stroke patients willing to participate during inpatient rehabilitation over 18 months and be randomized in this clinical trial to treatment with active or sham auto-titrating CPAP.
- Improve adherence to CPAP in all patients enrolled in this clinical trial. [ Time Frame: 18 months ]Number of enrolled stroke patients using CPAP, regardless of treatment allocation, meeting the goal of at least 4 hours per night CPAP adherence at hospital discharge.
- The effect of auto-titrating CPAP on neurological recovery compared to sham-CPAP. [ Time Frame: 18 months ]The median change in the Functional Independence Measure (FIM) between admission and discharge from the rehabilitation unit comparing active-CPAP versus sham-CPAP. The FIM, a sensitive disability scale, is an 18-item instrument measuring the burden of care associated with aspects of motor and cognitive function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551757
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195-9470|
|Principal Investigator:||Sandeep Khot, MD||Associate Professor, Dept. Neurology|