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. 2017 Feb 20;2017(2):CD002769. doi: 10.1002/14651858.CD002769.pub5

Gozal 1997.

Methods RCT.
Cross‐over design.
Duration: 3 nights within a 15‐day period.
Participants Six participants with CF and moderate to severe lung disease and significant gas exchange abnormalities during sleep. Stable participants.
 Age mean (SD) [range]: 22.3 (4.7) [13 ‐ 28].
FEV₁% predicted mean (SD): 29.4% (3.4).
Interventions Session 1: room air.
 Session 2: night‐time bilevel NIPPV with supplemental oxygen given via nasal mask.
Outcomes TST; sleep latency; NREM; NREM %TST; REM min; REM %TST; undetermined % TST; total arousals; arousal index; SaO₂; TcCO₂.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated as randomised, methods not discussed.
Allocation concealment (selection bias) Unclear risk Not discussed.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Participants were obviously aware of the intervention being administered; however, all were reportedly unaware of the purpose of the trial with participants and sleep technicians blinded to the results until completion of the third night.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 2 participants dropped out due to non‐tolerance of NIV; it was not explicitly stated that intention‐to‐treat was not used, but results are based on the remaining 6 participants who completed the trial.
Selective reporting (reporting bias) Low risk All outcome measures were reported.
Other bias Unclear risk Methods of statistical analysis were described.