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. |