Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
|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.
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|