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Open Access Study protocol

The effect of obstructive sleep apnea and treatment with continuous positive airway pressure on stroke rehabilitation: rationale, design and methods of the TOROS study

Justine A Aaronson135*, Coen AM van Bennekom1, Winni F Hofman3, Tijs van Bezeij1, Joost G van den Aardweg4, Erny Groet1, Wytske A Kylstra1 and Ben A Schmand23

Author Affiliations

1 Heliomare Research & Development, Relweg 51, 1949 EC Wijk aan Zee, The Netherlands

2 Department of Neurology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

3 Department of Psychology, University of Amsterdam, Weesperplein 4, 1018 XA Amsterdam, The Netherlands

4 Department of Pulmonary Medicine, Medical Centre Alkmaar, Wilhelminalaan 12, 1815 JD Alkmaar, The Netherlands

5 Heliomare, PO Box 78 1940 AB, Beverwijk, The Netherlands

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BMC Neurology 2014, 14:36  doi:10.1186/1471-2377-14-36

Published: 25 February 2014

Abstract

Background

Obstructive sleep apnea is a common sleep disorder in stroke patients. Obstructive sleep apnea is associated with stroke severity and poor functional outcome. Continuous positive airway pressure seems to improve functional recovery in stroke rehabilitation. To date, the effect of continuous positive airway pressure on cognitive functioning in stroke patients is not well established. The current study will investigate the effectiveness of continuous positive airway pressure on both cognitive and functional outcomes in stroke patients with obstructive sleep apnea.

Methods/Design

A randomized controlled trial will be conducted on the neurorehabilitation unit of Heliomare, a rehabilitation center in the Netherlands. Seventy stroke patients with obstructive sleep apnea will be randomly allocated to an intervention or control group (nā€‰=ā€‰2Ɨ35). The intervention will consist of four weeks of continuous positive airway pressure treatment. Patients allocated to the control group will receive four weeks of treatment as usual. Outcomes will be assessed at baseline, immediately after the intervention and at two-month follow-up.

In a supplementary study, these 70 patients with obstructive sleep apnea will be compared to 70 stroke patients without obstructive sleep apnea with respect to cognitive and functional status at rehabilitation admission. Additionally, the societal participation of both groups will be assessed at six months and one year after inclusion.

Discussion

This study will provide novel information on the effects of obstructive sleep apnea and its treatment with continuous positive airway pressure on rehabilitation outcomes after stroke.

Trial registration

Trial registration number: Dutch Trial Register NTR3412

Keywords:
Stroke; Rehabilitation outcome; Obstructive sleep apnea; CPAP; Randomized controlled trial; Cognition; Functional status