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

Laub 2017.

Methods Randomised controlled, parallel‐arm trial
Participants POSA
Participants randomised: 101
Inclusion criteria
  • AHI supine ≥ twice AHI non‐supine

  • AHI supine ≥ 10

  • AHI non‐supine < 10

  • 10%‐90% sleep time in supine position

  • Daytime tiredness and/or disturbed sleep and/or snoring


Exclusion criteria
  • Participant not able or willing to co‐operate

  • Age < 18 years

  • Central sleep apnoea

  • Night work or shift work

  • Clinical history of severe chronic heart failure or severe chronic obstructive pulmonary disease

  • Medical history of other known causes of daytime tiredness or severe sleep disruption (insomnia, periodic leg movements, narcolepsy)

  • Seizure disorder

  • Known medical history of mental retardation, memory disorders or psychiatric disorders

  • Inability to provide informed consent

  • Implanted pacemaker

  • Pain in hip or shoulder

  • Unable to sleep in lateral positions

  • Pregnancy or planned pregnancy in study period

  • Breastfeeding women in study period

  • Planned weight reduction in study period

  • Planned smoking cessation in study period

Interventions SPT, a vibrating supine alert device worn across participant's chest
Outcomes Primary: short‐term efficacy and adherence of the SPT over a 2‐month period
Secondary: long‐term efficacy and adherence of SPT for a 6‐month period
Notes Funding: "Maribo Medicos A/S Denmark and Night Balance, the Netherlands provided the SPT devices free of charge. "The authors state that the study was an independent investigator‐initiated study
Disclosure: "Philip Tonnesen has been a member of the steering committee for the annual sleep scientific meeting in Denmark arranged by Maribo Medico A/S"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated list of random numbers was used for randomisation
Allocation concealment (selection bias) Unclear risk The exact procedure adapted for allocation concealment not mentioned
Blinding of participants and personnel (performance bias) 
 Objective outcomes ( AHI) High risk Open‐label trial; no blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Outcome assessor blinding not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes High risk 26.7% of the participants dropped out before the first follow‐up at 2 months
Selective reporting (reporting bias) Unclear risk Protocol (NCT022114424) mentions similar outcomes to the report
Other bias Unclear risk None identified, except for the disclosure of the potential conflict of interest