Positional Therapy After Stroke

• ClinicalTrials.gov Identifier: NCT01047709
• Recruitment Status: Completed
• First Posted: January 13, 2010
• Results First Posted: June 10, 2013
• Last Update Posted: June 10, 2013
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Devin Brown, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea; Stroke	Device: Positional therapy including the use of a special pillow	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Positional Therapy After Stroke
• Study Start Date: December 2008
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

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.

• Responsible Party: Devin Brown, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01047709
• Other Study ID Numbers: U024133
• First Posted: January 13, 2010
• Results First Posted: June 10, 2013
• Last Update Posted: June 10, 2013
• Last Verified: June 2013

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases