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. 2006 Oct 18;2006(4):CD005308. doi: 10.1002/14651858.CD005308.pub2

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.
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)
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.
Outcomes 1) CPAP compliance
2) Side effects (10 cm visual analogue scale)
3) Mask preference
4) Epworth sleepiness score
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