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Clinical Trials/NCT01047709
NCT01047709
Completed
Phase 2

Positional Therapy After Stroke

University of Michigan1 site in 1 country18 target enrollmentDecember 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
University of Michigan
Enrollment
18
Locations
1
Primary Endpoint
Apnea-hypopnea Index
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
May 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Devin Brown

Associate Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • Probable ischemic stroke within prior 14 days

Exclusion Criteria

  • Any medical condition precluding the avoidance of supine posture or dictating the need for a particular position.
  • Current use of CPAP (or other PAP), mechanical ventilation, or supplemental oxygen.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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