Sleep Adjustment Strategy for Reducing Sedation Use in Pediatric Radiotherapy Under Surface Optical Monitoring: A Pragmatic Randomized Feasibility Trial.

Abstract

Young children undergoing radiotherapy (RT) frequently require pharmacologic sedation to achieve adequate immobilization, which is associated with procedural burden and potential adverse effects. We evaluated the feasibility and safety of a structured sleep-adjustment protocol (WASPE) for reducing sedation use during pediatric RT under surface optical monitoring. Children aged 0-4 years requiring RT for solid tumors were enrolled in this single-center, pragmatic randomized phase II feasibility trial (ClinicalTrials.gov NCT06443632) and randomized 2:1 to WASPE or standard chloral-hydrate sedation. All patients received image-guided intensity-modulated RT with cone-beam CT (CBCT) setup verification and real-time optical surface monitoring (OSMS). The primary endpoint was the per-fraction rate of RT completion without pharmacologic sedation in the WASPE arm, evaluated against a prespecified feasibility/non-inferiority threshold. Secondary endpoints included interfraction setup accuracy, intrafraction motion, exploratory immune and endocrine biomarkers, and treatment-related adverse events. Forty-eight patients were enrolled, with 32 assigned to WASPE and 16 to sedation. In the WASPE arm, 448 RT fractions were delivered, of which 432 (96.4%) were completed without pharmacologic sedation. The estimated marginal sedation-free completion rate was 96.2% (95% CI, 93.3%-97.9%), meeting the prespecified feasibility criterion. In the sedation arm, 7 children partially crossed over to WASPE, accounting for 110 of 238 control-arm fractions (46.2%). No clear signal of worsened CBCT-based setup accuracy or OSMS-based beam-on motion was observed with WASPE, although these secondary comparisons should be interpreted cautiously given crossover between randomized strategies. No significant group-by-time differences were observed in serum immunoglobulin or growth hormone levels. No grade ≥2 treatment-related adverse events occurred in either group. WASPE enabled a high rate of sedation-free RT delivery in children younger than 4 years and met the prespecified feasibility benchmark, without an obvious signal of compromised positional adequacy or serious short-term safety concern in this feasibility trial.