Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
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|ClinicalTrials.gov Identifier: NCT01703663|
Recruitment Status : Completed
First Posted : October 10, 2012
Results First Posted : October 13, 2016
Last Update Posted : October 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Obstructive Sleep Apnea||Device: EPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Provent Sleep Apnea Therapy.
Other Name: Provent Sleep Apnea Therapy.
|No Intervention: control|
- Apnea-hypopnea Index [ Time Frame: night 1 and night 2 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703663
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Devin L Brown, MD||University of Michigan|