Trial Outcomes & Findings for Stroke and CPAP Outcome Study 2 (NCT NCT02809430)

Results Overview

Number of participants who continue CPAP after the run-in period who have acceptable adherence at 3 months, defined as using CPAP for an average of at least 4 hours a night on at least 70% of nights.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

3 months

Results posted on

2020-12-23

Participant Flow

Over the 3-night run-in period with CPAP, 28 of the 90 patients enrolled (31%) were excluded: 14 with CPAP use \<3 hours, 5 with no evidence of OSA, and 9 with evidence of central or complex sleep apnea. A total of 62 eligible patients (69%) completed the run-in with evidence of OSA and chose to continue CPAP.

Participant milestones

Participant milestones
Measure	CPAP Intervention Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
Overall Study STARTED	90
Overall Study Failed 3-night run-in Because no Evidence of Obstructive Sleep Apnea	28
Overall Study Stopped CPAP During Inpatient Rehabilitation	10
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stroke and CPAP Outcome Study 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP Intervention n=90 Participants Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot problems with the device.
Age, Continuous	60.7 60.7 (SD 11.4) years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	8 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Among the 62 of the enrolled 90 patients (69%) with evidence of OSA, 52 (84%) patients chose to continue CPAP on inpatient rehabilitation discharge. Three-month CPAP adherence was evaluated in these 52 participants.

Number of participants who continue CPAP after the run-in period who have acceptable adherence at 3 months, defined as using CPAP for an average of at least 4 hours a night on at least 70% of nights.

Outcome measures

Outcome measures
Measure	CPAP Intervention n=52 Participants The intensive CPAP adherence protocol (iCAP) initiated during the run-in will be continued during inpatient rehabilitation, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their inpatient rehabilitation (IPR) stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants will be encouraged at the time of IPR discharge to continue CPAP therapy at home for a treatment period of 3 months from CPAP initiation. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.	Non-adherent Participants Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
3-month CPAP Adherence	32 participants adherent to CPAP at 90 days	—

SECONDARY outcome

Timeframe: Upon discharge from rehabilitation unit, typically at 14-21 days from CPAP initiation

Population: Participants with evidence of OSA during the 3-night run-in

Number of eligible participants (those who continue CPAP after the run-in period) who are willing to continue CPAP treatment upon discharge from the rehabilitation unit.

Outcome measures

Outcome measures
Measure	CPAP Intervention n=62 Participants The intensive CPAP adherence protocol (iCAP) initiated during the run-in will be continued during inpatient rehabilitation, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their inpatient rehabilitation (IPR) stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants will be encouraged at the time of IPR discharge to continue CPAP therapy at home for a treatment period of 3 months from CPAP initiation. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.	Non-adherent Participants Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
CPAP Tolerance	52 Participants	—

SECONDARY outcome

Timeframe: Between admission to rehabilitation unit and between 3-4 months following enrollment

Change in the cognitive subscale of the Functional Independence Measure (FIM) over 3 months. The FIM, a disability scale measuring the burden of care associated with aspects of motor and cognitive function, includes a motor and cognitive component. The cognitive subscale includes 5 cognitive items: comprehension, expression, social interaction, problem solving and memory. Each of the 5 cognitive items are scored from 1 (complete dependence) to 7 (complete independence). The total scores from these 5 items for the cognitive subscale range from 5 to 35 with lower scores indicating greater functional disability. The 5 items from the cognitive subscale are combined with 13 items from the motor subscale yielding the 18 items of the total FIM with a minimum score of 18 and a maximum score of 126 with lower scores indicating greater functional disability.

Outcome measures

Outcome measures
Measure	CPAP Intervention n=32 Participants The intensive CPAP adherence protocol (iCAP) initiated during the run-in will be continued during inpatient rehabilitation, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their inpatient rehabilitation (IPR) stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants will be encouraged at the time of IPR discharge to continue CPAP therapy at home for a treatment period of 3 months from CPAP initiation. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.	Non-adherent Participants n=20 Participants Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
Change in the Cognitive Functional Independence Measure (FIM) Subscore	8.2 score on a scale Standard Deviation 6.5	4.6 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Between admission to rehabilitation unit and between 3-4 months following enrollment

Change in the motor subscale of the Functional Independence Measure (FIM) over 3 months. The FIM, a disability scale measuring the burden of care associated with aspects of motor and cognitive function, includes a motor and cognitive component. The motor subscale includes 13 motor items: eating, grooming, bathing, upper body dressing, lower body dressing, toileting, bladder management, bowel management, bed/chair transfer, toilet transfer, tub/shower transfer, walk/wheelchair locomotion and stair locomotion. Each of the 13 motor items are scored from 1 (complete dependence) to 7 (complete independence). The total scores from these 13 items for the motor subscale range from 13 to 91 with lower scores indicating greater functional disability. The 13 items from the motor subscale are combined with 5 items from the cognitive subscale yielding the 18 items of the total FIM with a minimum total score of 18 and a maximum score of 126 with lower scores indicating greater functional

Outcome measures

Outcome measures
Measure	CPAP Intervention n=32 Participants The intensive CPAP adherence protocol (iCAP) initiated during the run-in will be continued during inpatient rehabilitation, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their inpatient rehabilitation (IPR) stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants will be encouraged at the time of IPR discharge to continue CPAP therapy at home for a treatment period of 3 months from CPAP initiation. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.	Non-adherent Participants n=20 Participants Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
Change in the Motor Functional Independence Measure (FIM) Subscore	31.2 score on a scale Standard Deviation 15.7	30.2 score on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: NIHSS scores were obtained in-person on enrollment and at 90 ± 7 days from enrollment.

The National Institutes of Health Stroke scale (NIHSS) is a 15-item scale used to rank the severity of ischemic stroke. The NIHSS includes measurements for levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scores range from 0 to 42 with higher scores indicating greater neurologic impairment.

Outcome measures

Outcome measures
Measure	CPAP Intervention n=32 Participants The intensive CPAP adherence protocol (iCAP) initiated during the run-in will be continued during inpatient rehabilitation, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their inpatient rehabilitation (IPR) stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants will be encouraged at the time of IPR discharge to continue CPAP therapy at home for a treatment period of 3 months from CPAP initiation. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.	Non-adherent Participants n=20 Participants Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.
Change in NIH Stroke Scale	-3.8 score on a scale Standard Deviation 2.6	-1.6 score on a scale Standard Deviation 2.2

Adverse Events

CPAP Intervention

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

Dr. Sandeep Khot

University of Washington

Phone: 206-744-3251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place