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临床试验/NCT01047709
NCT01047709已完成2 期

Positional Therapy After Stroke

University of Michigan1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年12月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
18
试验地点
1
主要终点
Apnea-hypopnea Index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

positional therapy

Experimental

Avoidance of supine positioning.

干预措施: Positional therapy including the use of a special pillow (Device)

Control

No Intervention

Position ad lib.

结局指标

主要结局

Apnea-hypopnea Index

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Devin Brown

Associate Professor

University of Michigan

研究点 (1)

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