Trial Outcomes & Findings for Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients (NCT NCT02551757)
NCT ID: NCT02551757
Last Updated: 2021-01-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
18 months
Results posted on
2021-01-13
Participant Flow
Participant milestones
| Measure |
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.
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
|
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 interface 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: 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 t
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients
Baseline characteristics by cohort
| Measure |
Active-CPAP
n=20 Participants
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.
Auto-titrating CPAP was initiated after admit 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 CPAP adherence for patients treated with active-CPAP included education, desensitization of CPAP through brief periods of daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP.
|
Sham-CPAP
n=20 Participants
The sham-CPAP device was designed to entail no risks beyond those with CPAP and provide a high level of blinding. The sham-CPAP device has an internal flow restrictor and a modified elbow attached to the mask, which creates a larger than standard air leak that delivers a pressure of roughly 0.75 to 1 cm water. The modification is not noticeable when the device is fully assembled to avoid unblinding patients, providers, or study personnel. The elbow modification could only be used on standard nasal masks so full face masks and nasal pillows were excluded for patients in both active and sham-CPAP.
Sham-CPAP was initiated after admission to rehabilitation for the duration of rehabilitation but not exceeding 28 days. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included education, desensitization of CPAP through brief periods of daytime use and adjustments of humidity and mask, including addition of a chin strap.
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
56.5 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
56.2 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Eligible recruited participants included those randomized to sham or active CPAP during inpatient rehabilitation.
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.
Outcome measures
| Measure |
Eligible Recruited Participants: Active-CPAP
n=20 Participants
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.
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.
|
Eligible Recruited Participants: Sham-CPAP
n=20 Participants
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 has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel.
Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days.
|
|---|---|---|
|
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 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: up to 28 daysMean hours of nightly CPAP use, regardless of treatment allocation, at hospital discharge.
Outcome measures
| Measure |
Eligible Recruited Participants: Active-CPAP
n=13 Participants
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.
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.
|
Eligible Recruited Participants: Sham-CPAP
n=17 Participants
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 has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel.
Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days.
|
|---|---|---|
|
Hours of CPAP Per Night
|
3.9 hours of CPAP per night
Standard Deviation 2.7
|
3.6 hours of CPAP per night
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and discharge up to 28 daysThe 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.
Outcome measures
| Measure |
Eligible Recruited Participants: Active-CPAP
n=13 Participants
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.
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.
|
Eligible Recruited Participants: Sham-CPAP
n=17 Participants
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 has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel.
Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days.
|
|---|---|---|
|
Median Change in the Functional Independence Measure (FIM) Between Admission and Discharge From the Rehabilitation Unit Comparing Active-CPAP Versus Sham-CPAP.
|
34 scores on a scale
Interval 17.0 to 40.0
|
26 scores on a scale
Interval 20.0 to 32.0
|
Adverse Events
Active-CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham-CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place