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Poor recruitment. Funding expired.
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The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.
Stroke is the leading cause of adult disability in the United States, yet there are very few treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper airway blockage that occurs during sleep--is common after stroke, affecting more than half of stroke patients. The most common treatment for obstructive sleep apnea in the general population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
The objective of this single-center, prospective, randomized study is to evaluate CPAP treatment in post-stroke patients. Participants will go through a medical interview, a brief neurological examination, and a sleep study to screen them for OSA. Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP (placebo).
This project promises to establish feasibility, develop design and identify suitable outcome measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue, and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all stroke patients will become available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | CPAP |
|
| 2 | Sham Comparator | sham CPAP (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous positive airway pressure or CPAP | Device | RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. | 3 months | |
| Number of Subjects Who Withdraw From Study. | Prespecified outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index | Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devin Brown, MD, MS | Associate Professor, Stroke Program, University of Michigan | Principal Investigator |
| Lewis Morgenstern, MD | Director, Stroke Program, University of Michigan | Study Director |
| Jack Kalbfleisch, PhD | University of Michigan Dept of Biostatistics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21784661 | Result | Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016/j.jstrokecerebrovasdis.2011.06.010. Epub 2011 Jul 23. |
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Patients enrolled from inpatient neurology service.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Continuous Positive Airway Pressure (CPAP) | |
| FG001 | Sham Continuous Positive Airway Pressure (CPAP) | Subtherapeutic CPAP |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Continuous Positive Airway Pressure (CPAP) | |
| BG001 | Sham Continuous Positive Airway Pressure (CPAP) | Subtherapeutic CPAP |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. | Data not available on one sham participant (lowering n from 11 to 10 in the shame group). | Posted | Jun 2011 | Median | Inter-Quartile Range | Hours/participant | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Continuous Positive Airway Pressure (CPAP) |
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Attrition pre-randomization and while in randomized treatment led to small numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devin Brown, MD | University of Michigan | 734-936-9075 | devinb@umich.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| sham CPAP | Device | sham CPAP |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Subjects Who Withdraw From Study. | Prespecified outcome. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Barthel Index | Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent). | Posted | Median | Inter-Quartile Range | units on a scale (range 0-100) | 3 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Sham Continuous Positive Airway Pressure (CPAP) | Subtherapeutic CPAP | 0 | 17 | 0 | 17 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012138 |
| Respiratory Therapy |