Positional Therapy After Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan
ClinicalTrials.gov Identifier:
NCT01047709
First received: January 12, 2010
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Sleep Apnea
Stroke
Device: Positional therapy including the use of a special pillow
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Positional Therapy After Stroke

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Apnea-hypopnea Index [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: December 2008
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01047709

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Devin L Brown, MD, MS University of Michigan
  More Information

Publications:
Responsible Party: Devin Brown, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01047709     History of Changes
Other Study ID Numbers: U024133
Study First Received: January 12, 2010
Results First Received: January 18, 2013
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014