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problems with recruitment
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There are two purposes of this study. The first purpose is to define the frequency of obstructive sleep apnea in stroke survivors as well as its association with fatigue and quality of life. The second purpose is to determine if continuous positive airways pressure (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.
Stroke survivors frequently complain of fatigue, depressive symptoms, and decreased cognitive functioning. These burdens complicate the recovery and rehabilitation from stroke. While there may be many contributing factors to these burdens, one factor in particular may be both terribly common and yet readily susceptible to intervention. Consistent reports from around the world demonstrate that >50% of stroke patients have obstructive sleep apnea (OSA), a disorder that is also associated with fatigue, depressive symptoms, and decreased cognitive functioning. OSA is also associated with increases in inflammatory products which themselves are associated with the same array of burdens.
This study will examine inpatients at a stroke rehabilitation center. Patients' sleep will be studied. Patients with OSA will be randomized to 10 days treatment double blind with either continuous positive airways pressure (CPAP) treatment or to sub-therapeutic CPAP treatment. After 10 days of treatment, the OSA patients and the stroke patient without OSA will be restudied.
The study will shed light on the impact of OSA on stroke patients' burdens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Active Comparator | CPAP at therapeutic pressure |
|
| sub-therapeutic CPAP | Sham Comparator | CPAP administered at sub-therapeutic pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP at therapeutic pressure during nighttime |
| |
| CPAP at sub-therapeutic pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood States (POMS) - Fatigue Subscale | POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue | 10 days after beginning CPAP treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression (HADS) Scale -Depression Subscale | HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms | 10 days after beginning CPAP treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Dimsdale, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23019248 | Derived | Tomfohr LM, Hemmen T, Natarajan L, Ancoli-Israel S, Loredo JS, Heaton RK, Bardwell W, Mills PJ, Lee RR, Dimsdale JE. Continuous positive airway pressure for treatment of obstructive sleep apnea in stroke survivors: what do we really know? Stroke. 2012 Nov;43(11):3118-23. doi: 10.1161/STROKEAHA.112.666248. Epub 2012 Sep 27. No abstract available. |
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The study opened for enrollment on 9/16/09 at San Diego Rehabilitation Institute. Enrollment was halted in April 2011 and the study terminated due to low recruitment numbers.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP | CPAP at therapeutic pressure CPAP: CPAP at therapeutic pressure during nighttime |
| FG001 | Sub-therapeutic CPAP | CPAP administered at sub-therapeutic pressure CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP | CPAP at therapeutic pressure CPAP: CPAP at therapeutic pressure during nighttime |
| BG001 | Sub-therapeutic CPAP | CPAP administered at sub-therapeutic pressure CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | Profile of Mood States (POMS) - Fatigue Subscale | POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue | Data only available for 2 subjects; one subject did not provide data for this questionnaire. | Posted | Mean | Standard Deviation | units on a scale | 10 days after beginning CPAP treatment |
|
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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 | CPAP | CPAP at therapeutic pressure CPAP: CPAP at therapeutic pressure during nighttime |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joel Dimsdale | UCSD | jdimsdale@ucsd.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020181 | Sleep Apnea, Obstructive |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Device |
CPAP delivered at sub-therapeutic pressure at nighttime |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
|
|
| Secondary | Hospital Anxiety and Depression (HADS) Scale -Depression Subscale | HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms | Posted | Mean | Standard Deviation | units on a scale | 10 days after beginning CPAP treatment |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Sub-therapeutic CPAP | CPAP administered at sub-therapeutic pressure CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime | 0 | 0 | 0 | 0 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |