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.

Study Overview

• Status: Completed
• Conditions: Stroke; Sleep Apnea
• Intervention / Treatment: Device: Positional therapy including the use of a special pillow

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Sona Pillow.
No Intervention: Control; Position ad lib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea Index	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.	1 day

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Devin L Brown, MD, MS, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: U024133