Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke.
Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night.
Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPAP | Experimental | Provent Sleep Apnea Therapy. |
|
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPAP | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea Index | Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model. | night 1 and night 2 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Devin L Brown, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27306393 | Derived | Wheeler NC, Wing JJ, O'Brien LM, Hughes R, Jacobs T, Claflin E, Chervin RD, Brown DL. Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. J Clin Sleep Med. 2016 Sep 15;12(9):1233-8. doi: 10.5664/jcsm.6120. |
Not provided
Not provided
Not provided
Some subjects were discharged from the hospital between the first and second night and therefore dropped out.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EPAP Therapy First Night, Then Control Night | During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device. |
| FG001 | Control Night First Night, EPAP Therapy Second Night | During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Period |
| |||||||||||||
| Second Treatment Period |
|
All subjects who completed both nights
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Apnea-hypopnea Index | Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model. | Posted | Median | Inter-Quartile Range | apneas plus hypopneas per hour | night 1 and night 2 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EPAP Night |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devin L. Brown, MD, MS | University of Michigan | 734-936-9075 | devinb@umich.edu |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020181 | Sleep Apnea, Obstructive |
| D020521 | Stroke |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body mass index, self reported | Median | Inter-Quartile Range | kg/m^2 |
|
| NIH Stroke Scale | total (range 0-42; 0 is no findings) | Median | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Control Night | 0 | 19 | 0 | 19 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |