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NCT Number: NCT06837051

The Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With CRS

The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:

Is it possible that the device can treat postoperative olfactory dysfunction in patients with chronic sinusitis? Compared to the conventional device, how efficient is the modified olfactory training device for treating postoperative olfactory dysfunction in patients with chronic sinusitis?

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Key information

Conditions

Olfactory Dysfunction Chronic Rhinosinusitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Endoscopic sinus surgery is an effective treatment for treating olfactory dysfunction related to chronic rhinosinusitis. However, recent studies have shown that most patients experience a return of olfactory function to preoperative levels within months to a year after surgery. Clinically, olfactory training after endoscopic sinus surgery has been proven beneficial for the olfactory recovery.

The improved olfactory training device, based on a nasal bidirectional drug delivery system, can increase the deposition rate in the olfactory fissure region and improve the efficiency of olfactory training.

In this study, the investigators planned to recruit 213 patients and divided them into three groups for control group and olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on changes in cognitive function and the comparison of the outcomes of the three groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A diagnosis of CRSsNP based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS20).
  • The duration after endoscopic sinus surgery is 3months.
  • Olfactory dysfunction confirmed with the Sniffin's Sticks psychophysical test (TDI score≦30.5) .
  • Willingness to participate in this study and sign the informed consent form (ICF).

Exclusion criteria

  • Patients with olfactory impairment due to traumatic, congenital, toxic/drug-induced causes, tumors, or post-upper respiratory infections.
  • Lund-Mackay olfactory cleft score > 0.
  • Patients with severe comorbidities, such as malignant tumors.
  • Current or planned pregnancy prior to the end of study.
  • Patients who are unable to complete the study or are unable to comply with the requirements of the study (such as inability to tolerate olfactory function testing and treatment, memory or behavioral abnormalities, depression, smoking, heavy alcohol use, previous delinquent behavior)

Treatment and study plan

Conventional olfactory training device

Device

Four odorants are used: phenyl ethyl alcohol (PEA): rose, menthol: mint, citronellal: lemon, and eugenol: cloves. Training patients will receive four glass vials. Each contains one odorant (5 mL, soaked in cotton pads to prevent spilling) and is labeled with the name of the odorant.

Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

Modified olfactory training device

Device

The modified olfactory training device is based on the nasal bidirectional drug delivery system. The device uses breathing pressure to create positive pressure, significantly increasing the deposition rate of odors in the olfactory cleft area.

Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

Budesonide irrigation

Drug

Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

Primary outcomes

  1. The Sniffin's Sticks test

    Time frame: Baseline,Month 3,Month 6,Month 12

    A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)( more than 6 scores)

Secondary outcomes

  1. Olfactory cleft CT score

    Time frame: Baseline,Month 3,Month 6,Month 12

  2. Olfactory cleft endoscopy scale (OCES)

    Time frame: Baseline,Month 3,Month 6,Month 12

    The degree of discharge, nasal polyposis, edema, crusting, and scarring scores from 0 to 2 points for each measure. The sum of the olfactory cleft score on both sides is recorded for final results that ranged from 0 to 20 points. Higher scores indicate increased disease severity of the olfactory cleft.

  3. OB volume measurement

    Time frame: Baseline,Month 3,Month 6,Month 12

    MRI scans are performed using a 3T GE scanner with a 8-channel phase-array head coil. OB volumes are obtained by manual bordering and following addition of all slices, which are multiplied by the slice thickness to yield volume.

  4. Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)

    Time frame: Baseline,Month 3,Month 6,Month 12

    The QOD-NS includes 17 negative statements, each graded from 0 (disagree) to 3 (agree) for a maximum score of 51. Higher QOD-NS scores reflect worse QoL.

  5. Olfactory-Visual Analogue Scale (VAS)

    Time frame: Baseline,Month 3,Month 6,Month 12

    Subjects rate the impact of smell loss on their mood, ability to enjoy food, social interactions, safety, personal hygiene, sex life, ability to cook food, appetite and change in weight from 0 (no impact) to 10 (most impact) for a maximum score of 90. Higher olfactory-VAS scores reflect more severe impacts on daily life.

Study contacts

Contact information is provided by the study sponsor or research team.

Dawei Wu, MD, PhD

CONTACT

[email protected]

13522503401

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Protocol for a Randomized Controlled Trial Evaluating the Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With Chronic Rhinosinusitis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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