Study design (if review, criteria of inclusion for studies)
Randomized, parallel group study
Participants
29 Adult patients with CF and sleep desaturation.
Interventions
Non-invasive ventilation (NIV) compared to low-flow oxygen therapy (LFO2 ) for 12 months.
Outcome measures
Event-free survival was defined as participants without events. Events included: failure of therapy with PaCO2 > 60 mm Hg, or increase in PaCO2 > 10 mm Hg from baseline, increases in TcCO2 > 10 mm Hg, lung transplantation or death. Outcomes were measured at baseline, 3, 6 and 12 months, including lung function, ABG, Pittsburgh Sleep Quality Inventory (PSQI), SF36 and hospitalizations.
Main results
A total of 29 patients were randomized to NIV +/- O2 (n = 14) or LFO2 (n = 15) therapy for 12 months. Of the 29 patients, 18 met the criteria for event-free survival over 12 months. NIV +/- O2 group had 33% (95% CI: 5-58%) and 46% (95% CI: 10-68%) more event-free survival at 3 and 12 months than LFO2 group. No statistically significant differences were seen in spirometry, ABG, questionnaires or hospitalizations.
Authors' conclusions
NIV +/- O2 during sleep increases event-free survival over 12 months in adults with CF. Further studies are required to determine which subgroups benefit the most from NIV.