Mortimore 1998.
Methods | Randomised, crossover trial comparing nose and face mask CPAP therapy
Duration of study: 4 weeks in each arm. Not stated if washout period used. Method of randomisation: Unclear Allocation concealment: Unclear Blinding of participants: Not possible to blind interface type; Patients were not informed that study designed to assess compliance Blinding of technicians: CPAP titration performed using standard protocol by staff who were unaware of the trials Blinding of investigators: Not stated Withdrawals: None. Intention to treat analysis: No withdrawals. |
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Participants | 20 patients were enrolled in the study. Recruitment setting: Not stated Inclusion criteria: Newly diagnosed pts with sleep apnoea‐hypopnoea syndrome were enrolled after their CPAP titration night Exclusion criteria: Not stated Male/Female: Numbers not stated Age range: Not stated Mean age (SE): 52 (3) Mean BMI (SE): 32 (1) Mean AHI (SE): 34 (5.2) |
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Interventions | Nose mask (Resmed or Respironics) vs Face mask (Respironics) CPAP machine: Sullivan III, Resmed. Not stated if heated humidification used. Diagnostic study: CPAP titration performed using nose mask Therapeutic CPAP pressure: Not stated how this was determined. |
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Outcomes | 1) CPAP compliance 2) Side effects (10 cm visual analogue scale) 3) Mask preference 4) Epworth sleepiness score |
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Notes | The study also compared nose & face mask CPAP in patients with unsuccessful uvulopalatopharyngoplasties ‐ but this part of study was not randomised | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised; information not available |
Allocation concealment (selection bias) | Unclear risk | Information not available |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants: Not possible to blind interface type; Patients were not informed that study designed to assess compliance Technicians: CPAP titration performed using standard protocol by staff who were unaware of the trials Investigators: Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study |
AHI: apnoea‐hypopnoea index; CPAP: Continuous positive airway pressure; OSAHS: Obstructive sleep apnoea hypopnoea syndrome; PSG: Polysomnography; QoL: Quality of Life; RDI: Respiratiory disturbance index; vs: versus