Sleep Apnea, ObstructiveSCOUTS2NCT02809430
Stroke and CPAP Outcome Study 2
A study testing Continuous Positive Airway Pressure in people with Sleep Apnea, Obstructive and Stroke, run by University of Washington at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Stroke, Patient Adherence
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted after acute ischemic or hemorrhagic stroke to one of two inpatient rehabilitation units
Who cannot join
- The investigators will exclude participants if: their stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding); they have active CPAP use, advanced chronic lung disease requiring supplemental oxygen, heart failure (NYHA class III or IV); or they needed a nasogastric feeding tube.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195-9470
About this study
Official title: Maximizing Use of Continuous Positive Airway Pressure in Stroke Rehabilitation Patients With Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence. In this study, the investigators enrolled eligible stroke patients undergoing inpatient rehabilitation (IPR) into an intensive CPAP adherence protocol (iCAP) with an aim to increase tolerance and adherence to auto-titrating CPAP (APAP).
Read the detailed description
The SCOUTS (Stroke and CPAP Outcome Study 2) was a single-arm, open-label study performed at 2 IPR units of the University of Washington. Eligible stroke patients undergoing IPR were provided an intensive CPAP adherence protocol (iCAP) to increase tolerance and adherence to auto-titrating CPAP (APAP). The iCAP included patient education and encouragement, device adjustments, close monitoring of adherence and a 3-night run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP tolerance-- defined as participant willingness to continue APAP during IPR and over the 3-month treatment period. If both criteria were met, APAP treatment with iCAP continued during the rehabilitation stay and over a 3-month period. The goal of the intervention was to achieve 50% of subjects meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period. The investigators evaluated if demographic, co-morbid or stroke-specific factors predicted APAP adherence and assessed the relationship between APAP adherence and neurological recovery from stroke.
- Conditions
- Sleep Apnea, Obstructive, Stroke, Patient Adherence
- Being tested
- Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Stroke, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Auto-titrating Continuous Positive Airway Pressure (APAP) among patients admitted to a rehabilitation unit after ischemic or hemorrhagic stroke for 3 month treatment period.
| Study group | Role | What they receive |
|---|---|---|
| CPAP intervention | Experimental | 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. Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month CPAP Adherence
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.
Measured: 3 months
Secondary outcomes (4)
CPAP Tolerance
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.
Measured: Upon discharge from rehabilitation unit, typically at 14-21 days from CPAP initiation
Change in the Cognitive Functional Independence Measure (FIM) Subscore
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.
Measured: Between admission to rehabilitation unit and between 3-4 months following enrollment
Change in the Motor Functional Independence Measure (FIM) Subscore
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
Measured: Between admission to rehabilitation unit and between 3-4 months following enrollment
Change in NIH Stroke Scale
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.
Measured: NIHSS scores were obtained in-person on enrollment and at 90 ± 7 days from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Khot, University of Washington
- Investigators
- Sandeep Khot, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809430
- Sponsor's protocol ID
- 43428A
- Acronym
- SCOUTS2
- Status last verified
- Nov 2020
- First submitted
- 15 Jun 2016
- Last updated
- 23 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khot S, Barnett H, Davis A, Siv J, Crane D, Kunze A, Li Lue D, Bunnell A, McCann B, Bombardier C, Longstreth WT Jr, Watson N, Billings M. Intensive Continuous Positive Airway Pressure Adherence Program During Stroke Rehabilitation. Stroke. 2019 Jul;50(7):1895-1897. doi: 10.1161/STROKEAHA.119.024795. Epub 2019 May 20.
PubMed 31104619Khot SP, Barnett HM, Davis AP, Byun E, McCann BS, Bombardier CH, Rappisi K, Longstreth WT Jr, Billings ME, Brown DL, Garrison MM. Novel and modifiable factors associated with adherence to continuous positive airway pressure therapy initiated during stroke rehabilitation: An exploratory analysis of a prospective cohort study. Sleep Med. 2022 Sep;97:43-46. doi: 10.1016/j.sleep.2022.05.013. Epub 2022 May 26.
PubMed 35716543
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Use of Continuous Positive Airway Pressure in Stroke Rehabilitation Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02809430
- Acronym / sponsor ID
- SCOUTS2 / 43428A
- Conditions
- Sleep Apnea, Obstructive, Stroke, Patient Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 23 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence. In this study, the investigators enrolled eligible stroke patients undergoing inpatient rehabilitation (IPR) into an intensive CPAP adherence protocol (iCAP) with an aim to increase tolerance and adherence to auto-titrating CPAP (APAP).
Detailed description
The SCOUTS (Stroke and CPAP Outcome Study 2) was a single-arm, open-label study performed at 2 IPR units of the University of Washington. Eligible stroke patients undergoing IPR were provided an intensive CPAP adherence protocol (iCAP) to increase tolerance and adherence to auto-titrating CPAP (APAP). The iCAP included patient education and encouragement, device adjustments, close monitoring of adherence and a 3-night run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP tolerance-- defined as participant willingness to continue APAP during IPR and over the 3-month treatment period. If both criteria were met, APAP treatment with iCAP continued during the rehabilitation stay and over a 3-month period. The goal of the intervention was to achieve 50% of subjects meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period. The investigators evaluated if demographic, co-morbid or stroke-specific factors predicted APAP adherence and assessed the relationship between APAP adherence and neurological recovery from stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP intervention | Experimental | Device: Continuous Positive Airway PressureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted after acute ischemic or hemorrhagic stroke to one of two inpatient rehabilitation units
Key exclusion criteria (1 listed)
- The investigators will exclude participants if: their stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding); they have active CPAP use, advanced chronic lung disease requiring supplemental oxygen, heart failure (NYHA class III or IV); or they needed a nasogastric feeding tube.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureAuto-titrating Continuous Positive Airway Pressure (APAP) among patients admitted to a rehabilitation unit after ischemic or hemorrhagic stroke for 3 month treatment period. | Device | CPAP intervention |
Primary outcome
3-month CPAP Adherence
Time frame: 3 months
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.
4 secondary outcomes
CPAP Tolerance
Time frame: Upon discharge from rehabilitation unit, typically at 14-21 days from CPAP initiation
Change in the Cognitive Functional Independence Measure (FIM) Subscore
Time frame: Between admission to rehabilitation unit and between 3-4 months following enrollment
Change in the Motor Functional Independence Measure (FIM) Subscore
Time frame: Between admission to rehabilitation unit and between 3-4 months following enrollment
Change in NIH Stroke Scale
Time frame: NIHSS scores were obtained in-person on enrollment and at 90 ± 7 days from enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31104619Khot S, Barnett H, Davis A, Siv J, Crane D, Kunze A, Li Lue D, Bunnell A, McCann B, Bombardier C, Longstreth WT Jr, Watson N, Billings M. Intensive Continuous Positive Airway Pressure Adherence Program During Stroke Rehabilitation. Stroke. 2019 Jul;50(7):1895-1897. doi: 10.1161/STROKEAHA.119.024795. Epub 2019 May 20.
- Derived from this study: PubMed 35716543Khot SP, Barnett HM, Davis AP, Byun E, McCann BS, Bombardier CH, Rappisi K, Longstreth WT Jr, Billings ME, Brown DL, Garrison MM. Novel and modifiable factors associated with adherence to continuous positive airway pressure therapy initiated during stroke rehabilitation: An exploratory analysis of a prospective cohort study. Sleep Med. 2022 Sep;97:43-46. doi: 10.1016/j.sleep.2022.05.013. Epub 2022 May 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Khot, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure in people with Sleep Apnea, Obstructive and Stroke, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month CPAP Adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809430, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020; AzTrials last refreshed its copy on 27 Oct 2026.