Many patients continue to experience nocturnal heartburn or regurgitation despite taking a standard morning proton pump inhibitor (PPI). Current practice often escalates to a second (evening) PPI dose, while wedge pillows are recommended as a non-pharmacologic option—yet direct comparative evidence has been limited.
This randomized noninferiority trial enrolled patients with frequent nocturnal reflux symptoms despite at least four weeks of morning PPI therapy. Participants were randomized for four weeks to either (1) add a wedge pillow while continuing morning PPI, or (2) intensify to twice-daily PPI. Outcomes included nocturnal symptom burden (NGSSIQ), quality of life, sleep quality, daytime sleepiness, and objective reflux metrics using 24-hour pH-impedance monitoring. Pillow adherence was objectively tracked using a pressure-sensing timekeeper.
At four weeks, the wedge pillow strategy was non-inferior to twice-daily PPI for improving nocturnal reflux symptoms. Notably, sleep quality improved more with the wedge pillow. Objective reflux testing showed only limited differences between groups, suggesting that the symptomatic benefit may not be solely explained by measurable reductions in reflux episodes, and may involve improved sleep mechanics or arousal thresholds. Compliance and satisfaction with the pillow were high.
Clinical takeaway: For patients with persistent nocturnal reflux symptoms on morning PPI, adding a wedge pillow is a credible, low-risk alternative to escalating acid suppression—particularly when sleep disruption is a dominant complaint.