Trial Outcomes & Findings for Stroke and CPAP Outcome Study 3 (NCT NCT06029959)

NCT ID: NCT06029959

Last Updated: 2025-10-08

Results Overview

Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation
• Results posted on: 2025-10-08

Participant Flow

Between October 2023 and September 2024, 36 IPR patients with ischemic stroke or intracerebral hemorrhage were enrolled.

A single-night portable sleep apnea test was performed at a mean of 16.0 days from stroke onset and 4.0 days from IPR admission.

Participant milestones

Measure	SCOUTS3 Optimization Arm In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.
Overall Study STARTED	36
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure

SCOUTS3 Optimization Arm In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.

Overall Study Physician Decision

6

Baseline Characteristics

Stroke and CPAP Outcome Study 3

Baseline characteristics by cohort

Measure	SCOUTS3 Optimization Arm n=36 Participants In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.
Age, Customized Age	56.7 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Respiratory event index (REI)	21.3 events per hour STANDARD_DEVIATION 14.7 • n=5 Participants
Oxygen desaturation index (ODI)	18.1 events per hour STANDARD_DEVIATION 14.4 • n=5 Participants

PRIMARY outcome

Timeframe: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation

Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months

Outcome measures

Measure

SCOUTS3 Optimization Arm n=30 Participants In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.

CPAP Adherence

3.1 nightly hours of CPAP use Standard Deviation 2.6

Adverse Events

SCOUTS3 Optimization Arm

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

Sandeep Khot, MD

University of Washington

Phone: 206-744-3251

Email: skhot@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place