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

Area of Science:

• Otolaryngology
• Neuroscience
• Medical Devices

Background:

• Endoscopic sinus surgery treats chronic rhinosinusitis (CRS)-related olfactory dysfunction.
• Post-surgery olfactory recovery often returns to baseline within a year.
• Olfactory training is beneficial for post-sinonasal surgery olfactory recovery.

Purpose of the Study:

• To evaluate the efficacy of olfactory training for postoperative olfactory dysfunction in CRS patients.
• To compare a modified olfactory training (MOT) device with a conventional olfactory training (COT) device.
• To assess the therapeutic effects of MOT versus COT in improving olfactory function.

Main Methods:

• A randomized controlled trial involving 12 months of follow-up.
• Participants allocated to MOT, COT, or control groups (1:1:1 ratio).
• Primary outcome: changes in odor threshold, discrimination, and identification scores.

Main Results:

• The study aims to determine the effectiveness of MOT and COT in improving olfactory function.
• Secondary outcomes include objective olfactory cleft assessment and neuroimaging of olfactory structures.
• Subjective olfactory assessments will also be conducted.

Conclusions:

• The study will elucidate the comparative effectiveness of MOT and COT for olfactory recovery.
• Findings may inform the development of improved olfactory training devices.
• This research addresses limitations of conventional devices regarding odorant deposition.