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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
Sponsor:
Information provided by (Responsible Party):
Sandeep Khot, University of Washington

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.


Condition or disease Intervention/treatment Phase
Stroke Sleep Apnea, Obstructive Device: Auto-titrating CPAP Device: Sham-CPAP Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Active-CPAP
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.
Device: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195-9470
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Sandeep Khot, MD Associate Professor, Dept. Neurology
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Responsible Party: Sandeep Khot, Associate Professor, Dept. of Neurology, University of Washington
ClinicalTrials.gov Identifier: NCT02551757    
Other Study ID Numbers: 43428-A
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015
Keywords provided by Sandeep Khot, University of Washington:
Rehabilitation
Continuous Positive Airway Pressure
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders