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. 2019 May 1;2019(5):CD010990. doi: 10.1002/14651858.CD010990.pub2

Svatikova 2011.

Methods Randomised cross‐over trial
Participants Acute ischaemic stroke or probable ischaemic stroke
Participants included: 18
 Diagnosis based on the WHO MONICA criteria
 ≥ 18 years
 Gender: male 11 (61%); female 7 (39%)
 Age: 54‐68
Inclusion criteria
  • Ischemic stroke or probable Ischaemic stroke‐ WHO MONICA criteria

  • Age ≥ 18 years


Exclusion criteria
  • Any medical condition that precluded the avoidance of supine position or dictated the need for a particular position

  • Patients already on positive airway pressure therapy, mechanical ventilation or supplemental oxygen

Interventions Intervention: positional device called Sona pillow‐ designed to prevent supine sleep
 Control: standard hospital pillow, participant positioned at liberty
 Duration: 2 consecutive nights‐ 1 night with intervention and 1 night without intervention
Outcomes
  • Relative change in AHI with the intervention

  • Absolute difference in the mean SaO2

  • Absolute difference in the time spend in the supine position

  • Self‐reported adherence in the 3‐month follow‐up period (phase II of the study)

Notes Settings: inpatient neurology service, University of Michigan
 Duration of follow‐up: 3‐month follow‐up as the continuation for assessment of adherence
 Drop out: nil
 Funding: University of Michigan Clinical and translational science award
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation procedure not stated. High risk may be mitigated by the cross‐over design of the study.
Allocation concealment (selection bias) Unclear risk Allocation concealment procedure not stated. High risk may be mitigated by the cross‐over design of the study.
Blinding of participants and personnel (performance bias) 
 Objective outcomes ( AHI) High risk Blinding not mentioned, but likely not blinded considering the nature of the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No attrition
Selective reporting (reporting bias) Unclear risk Unclear as we could not access the protocol of the study
Other bias Low risk None identified