Laub 2017.
Methods | Randomised controlled, parallel‐arm trial | |
Participants | POSA Participants randomised: 101 Inclusion criteria
Exclusion criteria
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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 |
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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" |
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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 |