A Phase 1/2 interventional study of Auto-titrating CPAP and Sham-CPAP in Stroke and Sleep Apnea, Obstructive, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by University of Washington · Phase 1/2, Interventional, and Treatment
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.
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's enrollment of 40 is below the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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
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
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-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.
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.
Time frame: 18 months
Hours of CPAP Per Night
Mean hours of nightly CPAP use, regardless of treatment allocation, at hospital discharge.
Time frame: up to 28 days
Median Change in the Functional Independence Measure (FIM) Between Admission and Discharge From the Rehabilitation Unit Comparing Active-CPAP Versus Sham-CPAP.
The Functional Independence Measure (FIM), a sensitive disability scale, is an 18-item instrument measuring the burden of care associated with aspects of motor and cognitive function. Higher scores represent better stroke recovery where scores for each of the 18 items range from 1 (complete dependence) to 7 (complete independence). The overall FIM score ranges between 18 and 126. The FIM score can also be further broken down based on its motor and cognitive components. The 13 items of the motor FIM subscale range between 13 and 91, whereas the 5 items of the cognitive FIM subscale can range between 5 and 35. The motor and cognitive sub scales are summed to provide the total FIM score and the difference between the FIM scores on admission to the rehabilitation unit and discharge from the unit were calculated for each eligible participant.
Time frame: Baseline and discharge up to 28 days
| Milestone | Active-CPAP | Sham-CPAP |
|---|---|---|
| Started | 20 | 20 |
| Completed | 13 | 17 |
| Not completed | 7 | 3 |
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.
| Participants | Eligible Recruited Participants: Active-CPAP | Eligible Recruited Participants: Sham-CPAP |
|---|---|---|
| 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. | 13 | 17 |
Mean hours of nightly CPAP use, regardless of treatment allocation, at hospital discharge.
| hours of CPAP per night | Active-CPAP | Sham-CPAP |
|---|---|---|
| Hours of CPAP Per Night | 3.9 ± 2.7 | 3.6 ± 1.8 |
The Functional Independence Measure (FIM), a sensitive disability scale, is an 18-item instrument measuring the burden of care associated with aspects of motor and cognitive function. Higher scores represent better stroke recovery where scores for each of the 18 items range from 1 (complete dependence) to 7 (complete independence). The overall FIM score ranges between 18 and 126. The FIM score can also be further broken down based on its motor and cognitive components. The 13 items of the motor FIM subscale range between 13 and 91, whereas the 5 items of the cognitive FIM subscale can range between 5 and 35. The motor and cognitive sub scales are summed to provide the total FIM score and the difference between the FIM scores on admission to the rehabilitation unit and discharge from the unit were calculated for each eligible participant.
| scores on a scale | Active-CPAP | Sham-CPAP |
|---|---|---|
| Median Change in the Functional Independence Measure (FIM) Between Admission and Discharge From the Rehabilitation Unit Comparing Active-CPAP Versus Sham-CPAP. | 34 (17 to 40) | 26 (20 to 32) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active-CPAP | — | 0/20 (0%) | 0/20 (0%) |
| Sham-CPAP | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Active-CPAP | Sham-CPAP | Total |
|---|---|---|---|
| Mean | 55.9 ± 12.1 | 56.5 ± 12.1 | 56.2 ± 11.9 |
| Sex: Female, Male(Participants) | Active-CPAP | Sham-CPAP | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 10 | 12 | 22 |
| Race (NIH/OMB)(Participants) | Active-CPAP | Sham-CPAP | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 4 | 0 | 4 |
| Black or African American | 2 | 2 | 4 |
| White | 11 | 12 | 23 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Active-CPAP | Sham-CPAP | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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