Positional Therapy After Stroke
|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|
|Primary Completion Date :||February 2010|
|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.
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|