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

January 12, 2010
June 6, 2013
December 2008
February 2010   (final data collection date for primary outcome measure)
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.
  • apnea-hypopnea index [ Time Frame: comparison of nights one and two ] [ Designated as safety issue: No ]
  • apnea-hypopnea index [ Time Frame: nights one and two comparison ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01047709 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Positional Therapy After Stroke
Positional Therapy After Stroke

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea
  • Stroke
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.
  • Experimental: positional therapy
    Avoidance of supine positioning.
    Intervention: Device: Positional therapy including the use of a special pillow
  • No Intervention: Control
    Position ad lib.
Svatikova A, Chervin RD, Wing JJ, Sanchez BN, Migda EM, Brown DL. Positional therapy in ischemic stroke patients with obstructive sleep apnea. Sleep Med. 2011 Mar;12(3):262-6. doi: 10.1016/j.sleep.2010.12.008.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01047709
U024133
No
Devin Brown, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Devin L Brown, MD, MS University of Michigan
University of Michigan
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP