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. 2024 Nov 14;14(11):e087234. doi: 10.1136/bmjopen-2024-087234

Table 1. Schedule of assessments and interventions by visit.

Visit number Conventional (control) mask group Customised (intervention) mask group
1
  • Informed consent

  • Facial scanning

  • Physical assessment, including the presence of dermatitis, pressure ulcers, and eye symptoms. Vital measurements: SpO2, weight, height, BMI.

  • Demographics, Waterlow score, Co-morbidities, Rockwood frailty score

  • Questionnaires: ESS, SWIFT and S3NIV

  • PAP therapy device issued with conventional mask

  • Informed consent

  • Facial scanning for production of customised 3D printed mask

  • Physical assessment, including the presence of dermatitis, pressure ulcers and eye symptoms. Vital measurements: SpO2, weight, height, BMI.

  • Demographics, Waterlow score, Co-morbidities, Rockwood frailty score

  • Questionnaires: ESS, SWIFT and S3NIV

1a
  • PAP therapy device issued with a customised mask

2 Three months after the first visit
  • Physical assessment as per visit 1

  • Download data from the PAP machine

  • Questionnaires as per visit 1 plus interface questionnaire

  • 2-night cardiorespiratory sleep study

  • Adverse events review

Three months after visit 1a
  • Physical assessment as per visit 1

  • Download data from the PAP machine

  • Questionnaires as per visit 1 plus interface questionnaire

  • 2-night cardiorespiratory sleep study

  • Adverse events review

3 Six months after visit 1
  • Physical assessment as per visit 1

  • Download data from the PAP machine

  • Questionnaires as per visit 2

  • 2-night cardiorespiratory sleep study

  • Adverse events review

Six months after visit 1a
  • Physical assessment as per visit 1

  • Download data from the PAP machine

  • Questionnaires as per visit 2

  • 2-night cardiorespiratory sleep study

  • Adverse events review

  • Issue conventional mask for ongoing treatment

BMIbody mass indexESSEpworth Sleepiness ScorePAPpositive airway pressureS3NIVS3 Non-Invasive VentilationSWIFTSleepiness-Wakefulness Inability and Fatigue Test