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: SpO_2, 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: SpO_2, 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

BMI, body mass index; ESS, Epworth Sleepiness Score; PAP, positive airway pressure; S3NIV, S3 Non-Invasive Ventilation; SWIFT, Sleepiness-Wakefulness Inability and Fatigue Test.