Protocol for a randomised controlled trial evaluating the effect of modified olfactory training on postoperative...

Endoscopic sinus surgery is an effective treatment for olfactory dysfunction related to chronic rhinosinusitis (CRS). However, recent studies have shown that most patients with CRS experience a return of olfactory function to preoperative levels within months to a year after surgery. Clinically, olfactory training after sinonasal surgery has been proven beneficial for olfactory recovery. The study aims to explore the effectiveness of olfactory training in treating postoperative olfactory dysfunction in patients with CRS after surgery. Additionally, conventional olfactory training (COT) devices have the drawback of insufficient deposition rates of odourants in the olfactory cleft, leading to poor treatment outcomes. This experiment employs a modified olfactory training (MOT) device based on respiratory pressure and compares its therapeutic effects with the COT device.

This will be a randomised controlled trial. The aim is to investigate the effectiveness of olfactory training in treating postoperative olfactory dysfunction in patients with CRS and to compare the effects of MOT with COT. Participants will be randomly allocated in a 1:1:1 ratio to the MOT group, the COT group and the control group for 12 months. The primary outcome will be the change in the odour threshold, odour discrimination, odour identification and the total threshold, detection and identification score after 12 months of olfactory training. The secondary outcomes will include objective olfactory cleft assessment, the volumes of grey matter, white matter and cerebrospinal fluid, the volume and shape of the olfactory bulb, and the subjective olfactory assessment.

This study protocol has been registered with ClinicalTrials.gov and has received approval from the Peking University Third Hospital Medical Science Research Ethics Committee. The results will be published in scientific peer-reviewed journals.

NCT06837051.