Positional Therapy After Stroke
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|ClinicalTrials.gov Identifier: NCT01047709|
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Stroke||Device: Positional therapy including the use of a special pillow||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Positional Therapy After Stroke|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||May 2010|
Experimental: positional therapy
Avoidance of supine positioning.
Device: Positional therapy including the use of a special pillow
Avoidance of supine sleep via a special pillow and other measures.
Other Name: Sona Pillow.
No Intervention: Control
Position ad lib.
- Apnea-hypopnea Index [ Time Frame: 1 day ]Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of presumed sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The relative treatment effect on AHI using GEE modeling.
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): NCT01047709
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Devin L Brown, MD, MS||University of Michigan|