Positional Therapy After Stroke



Status:Archived
Conditions:Insomnia Sleep Studies, Neurology, Pulmonary
Therapuetic Areas:Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2008
End Date:August 2010

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Stroke is the leading cause of adult disability and the third leading cause of death in the
United States. Unfortunately, there are few therapies that have been proven to improve
stroke outcome. Sleep apnea is an emerging stroke risk factor and has a well established
association with higher mortality and poor functional outcome following stroke. Over half of
acute stroke patients have sleep apnea, suggesting that it may be a important target for
therapy. Attenuation of sleep apnea severity may result in improved stroke outcomes.
However, the standard treatment for sleep apnea is not well-tolerated among stroke patients.
An alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute
stroke patients, and therefore this treatment may have particular relevance to the stroke
population. The proposed study will be conducted in two phases. The first phase is a
randomized, crossover design in which acute stroke patients will be given positional
treatment (to avoid supine sleep) on one night during their stroke hospitalization. This
will be compared with another night of sleeping without positional therapy. The order of
treatments (standard vs positional therapy) will be random. The first phase will demonstrate
the proof of concept: that stroke patients given positional therapy to avoid supine sleep
will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with
positional therapy. In the second phase, those identified to have sleep apnea will be
randomized to receive positional therapy at home for three months, or standard therapy. This
second phase will demonstrate the adherence/feasibility of three months of positional
therapy, and will allow us to estimate effect size based on a functional outcome measure.
The data obtained from this pilot clinical trial are essential to plan a large efficacy
study.



We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health Systems The University of Michigan is home to one of the...
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Ann Arbor, MI
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