Ischemic Stroke, Intra Cerebral Hemorrhage, Obstructive Sleep Apnea, Adherence, Treatment, Motivation
Conditions
Keywords
behavioral therapy, continuous positive airway pressure, rehabilitation therapy, stroke recovery, self determination
Brief summary
A problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases the risk of stroke and is common in people who have had a stroke, present in about 2/3 of stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during intensive stroke rehabilitation.
Detailed description
In an initial single-arm study, participants with stroke will be tested for OSA and treated with auto-titrating CPAP during inpatient stroke rehabilitation and continued for a 3-month treatment period. Multiple behavioral interventions will be used to improve CPAP use, including intensive CPAP technical support, motivational enhancement therapy, and phone and mobile health automated support. The multicomponent behavioral intervention will be optimized to improve CPAP adherence with the engagement and input of stroke survivors.
Interventions
DEVICEContinuous positive airway pressure (CPAP)
Eligible participants with a diagnosis of OSA will be set up with autotitrating CPAP by the study's sleep technologist. The CPAP device includes an auto-titrator that adjusts the delivered pressure between 5 to 15 cm of water to eliminate obstructive events.
BEHAVIORALCPAP technical support intervention
SCOUTS 3 sleep technologists (ST) will make mask type/size or device adjustments, as needed, and provide training to participants and CPAP partners to improve skills involved with mask placement and device maintenance. For participants with non-acceptance of CPAP over the first night, a standardized desensitization program will be implemented. Persistent problems with CPAP use or mask fit, or any high residual respiratory events will be discussed between the sleep technologist and the study's board-certified sleep medicine physician.
BEHAVIORALMotivational Enhancement Therapy (MET)
In-person Motivational Enhancement Therapy (MET) sessions by a trained sleep coach will occur within a week of starting CPAP and, with permission, conducted with a CPAP partner, when available. The MET session recordings will be uploaded into the HIPAA compliant Lyssn platform for evaluation, including feedback to the sleep coach. The goal will be 5 total MET sessions, either in-person or by phone, spanning the inpatient and then outpatient settings.
BEHAVIORALMobile Health intervention
Study participants will be assisted in registering for and trained on the ResMed myAir app. Participants will also receive mobile health messages based on Self-Determination Theory.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days * Person providing consent (patient or legally authorized representative) able to be consented in English or Spanish
Exclusion criteria
* Unable to obtain informed consent from participant or surrogate * Incarcerated * Known pregnancy * Current mechanical ventilation, tracheostomy or supplemental oxygen use \> 4L/min * Current use of positive airway pressure or use within 14 days prior to stroke * History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use * Stroke related to tumors, vascular malformations or subarachnoid hemorrhage * Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) * Anticipated inpatient rehabilitation length of stay \< 3 nights
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Adherence | 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 |
Countries
United States
Participant flow
Recruitment details
Between October 2023 and September 2024, 36 IPR patients with ischemic stroke or intracerebral hemorrhage were enrolled.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
Baseline characteristics
| Characteristic | SCOUTS3 Optimization Arm |
|---|---|
| Age, Customized Age | 56.7 years STANDARD_DEVIATION 15.5 |
| Oxygen desaturation index (ODI) | 18.1 events per hour STANDARD_DEVIATION 14.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Respiratory event index (REI) | 21.3 events per hour STANDARD_DEVIATION 14.7 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
CPAP Adherence
Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months
Time frame: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCOUTS3 Optimization Arm | CPAP Adherence | 3.1 nightly hours of CPAP use | Standard Deviation 2.6 |