Domiziana Nardelli

Background/Objectives: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory condition that significantly impairs health-related quality of life (HRQoL), particularly sleep quality. Beyond mechanical nasal obstruction, type 2 cytokines (IL-4, IL-13) are thought to directly disrupt sleep architecture. Dupilumab, an IL-4Rα antagonist, is approved for severe CRSwNP, but its specific effect on sleep quality remains under investigation. This systematic review aims to evaluate the impact of dupilumab on sleep quality in patients with severe, uncontrolled CRSwNP. Methods: A comprehensive literature search was conducted in PubMed/MEDLINE, Google Scholar, and Web of Science up to June 2026. We included adult studies (≥1 month of dupilumab 300 mg every 15 days) reporting sleep outcomes using validated tools (Epworth Sleepiness Scale [ESS], Pittsburgh Sleep Quality Index [PSQI], Insomnia Severity Index [ISI], or the SNOT-22 sleep domain). Risk of bias was assessed using ROBINS-I and RoB 2 tools. Results: Seven studies (n = 2164 patients) met inclusion criteria. Across observational and post hoc RCT analyses, dupilumab consistently improved the SNOT-22 sleep domain (mean reduction up to −7.02 points at 24 weeks; p < 0.001), PSQI, ESS, and ISI scores. One study reported a decrease in poor global sleep quality from 88.9% at baseline to 5.7% at 12 months. However, most observational studies had a serious risk of bias due to unaddressed confounding and lack of blinding. No polysomnographic data were reported. Conclusions: Dupilumab was associated with significant improvements in patient-reported sleep quality in CRSwNP patients across seven included studies. However, the evidence is limited by the absence of objective sleep measures, the serious risk of bias in most observational studies, and the lack of comparative head-to-head data. High-quality randomized controlled trials with prespecified sleep endpoints and polysomnographic assessments are needed before definitive conclusions can be drawn.

Purpose This systematic review consolidates current evidence on the efficacy, safety, and tolerability of awake, office-based procedures for chronic rhinosinusitis (CRS). It aims to evaluate whether these minimally invasive interventions performed under local anesthesia are viable alternatives to conventional sinus surgery under general anesthesia. Methods A systematic search of PubMed/MEDLINE, Google Scholar, and Scopus databases was performed through November 2025, following PRISMA guidelines. Studies were selected using the PICOS framework, including adult patients undergoing in-office procedures (e.g., balloon sinus dilation, endoscopic sinus surgery, polypectomy, steroid-eluting implant placement) for CRS. Data were extracted and narratively synthesized due to heterogeneity. Results Eleven studies involving 1,283 patients were included. The procedures demonstrated significant and sustained improvements in patient-reported (SNOT-22, SNOT-20, NOSE, VAS) and objective (Lund-Mackay, Nasal Polyp Score) outcomes. Complication rates were low, with minor adverse events. Intraoperative pain was generally mild, tolerability was high (82–95%), and patients reported rapid recovery (often within 48 h) and high satisfaction (72–95% willing to repeat the procedure). Conclusion Awake sinus procedures are an effective, safe, and well-tolerated treatment option for selected CRS patients. They offer significant symptom relief, high patient satisfaction, and rapid recovery while avoiding general anesthesia. These techniques represent a transformative, patient-centered, and resource-efficient component of modern rhinology.

Background: Postoperative bleeding is a frequent complication in otolaryngology and head and neck surgery, often leading to readmissions and increased healthcare costs. Objectives: This systematic review evaluates the clinical efficacy, safety, and impact of RADA16, a synthetic self-assembling peptide hydrogel, as a topical haemostatic adjunct in this surgical field. Methods: In adherence with PRISMA 2020 guidelines, a systematic search of PubMed, Scopus, and Web of Science was conducted through December 2025. Eligible studies included adult patients undergoing otolaryngological or head and neck surgical procedures where RADA16 (CAS 289042-25-7, PuraBond^®/PuraStat^®/PuraGel^®, ^®, 3-D Matrix SAS; Caluire et Cuire, Lyon, France) was applied intraoperatively. Exclusion criteria included non-English publications, reviews, and studies without clinical outcome data. Risk of bias was assessed using the Cochrane Risk of Bias tool for RCTs and the Newcastle-Ottawa Scale for observational studies. A narrative synthesis was performed due to heterogeneity in outcome reporting. Results: Eight studies involving 1761 patients were included. In oropharyngeal surgery, RADA16 significantly reduced postoperative haemorrhage (6.3% vs. 16.7%, p = 0.016) and was associated with faster resumption of normal diet and lower pain scores (p = 0.016). In nasal surgery, it significantly lowered epistaxis rates (0.4% vs. 2.2%, adjusted OR 0.027, p = 0.026) and reduced the need for nasal packing. In cervical endocrine surgery, the rate of hematoma requiring revision was low (0.84%), with no delayed bleeding beyond 24 h. Surgeons consistently reported high satisfaction and ease of application. No serious device-related adverse events were reported. Discussion: Current evidence suggests RADA16 is a safe and effective haemostatic adjunct that can improve postoperative recovery and reduce readmission rates in specific surgical contexts. Limitations include heterogeneity in study designs, small sample sizes in some domains, and a lack of long-term follow-up. Further large-scale randomized controlled trials are needed to quantify its economic impact and formalize its role in surgical pathways. Funding: This study was funded by 3-D Matrix Medical Technology for article processing charges. The funder had no role in study design, data collection, analysis, interpretation, or writing. Registration: This review was not registered in a systematic review registry.