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

February 14, 2025 updated by: Dawei Wu, Peking University Third Hospital

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with olfactory impairment due to traumatic, congenital, toxic/drug-induced causes, tumors, or post-upper respiratory infections.
  2. Lund-Mackay olfactory cleft score > 0.
  3. Patients with severe comorbidities, such as malignant tumors.
  4. Current or planned pregnancy prior to the end of study.
  5. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The Conventional Olfactory Training Group
Patients are instructed to use the conventional olfactory training device at home twice daily, before breakfast and at bedtime. Four odors will be used: rose, mint, lemon, and clove. In each training session, participants are exposed to each odor for a duration of 10 seconds, followed by a 10-second break before the next odor is presented. Each training session lasts 5 minutes and is conducted for a duration of 12 months. All the patients will be treated with budesonide irrigations. Saline irrigations will be administered twice daily for 12 months using a NeilMed™ (NeilMed, Santa Rosa, CA) squeeze bottle along with salt packets and either distilled or filtered water. 2 mL of 0.5 mg/ 2 mL budesonide (Pulmicort Respules, AstraZeneca Canada, Mis sissauga, ON, Canada) will be added to the irrigation bottles of the patients.
Device: Conventional olfactory training 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.
Experimental: The Modified Olfactory Training Group
Patients are instructed to use a modified olfactory training device based on expiratory pressure at home twice daily, before breakfast and at bedtime. Four odors will be used: rose, mint, lemon, and clove. In each training session, participants are exposed to each odor for a duration of 10 seconds, followed by a 10-second break before the next odor is presented. Each training session lasts 5 minutes and is conducted for a duration of 12 months. All the patients will be treated with budesonide irrigations. Saline irrigations will be administered twice daily for 12 months using a NeilMed™ (NeilMed, Santa Rosa, CA) squeeze bottle along with salt packets and either distilled or filtered water. 2 mL of 0.5 mg/ 2 mL budesonide (Pulmicort Respules, AstraZeneca Canada, Mis sissauga, ON, Canada) will be added to the irrigation bottles of the patients.
Device: Modified olfactory training 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.
Sham Comparator: The Control Group
Participants will not receive any olfactory training. All the patients will be treated with budesonide irrigations. Saline irrigations will be administered twice daily for 12 months using a NeilMed™ (NeilMed, Santa Rosa, CA) squeeze bottle along with salt packets and either distilled or filtered water. 2 mL of 0.5 mg/ 2 mL budesonide (Pulmicort Respules, AstraZeneca Canada, Mis sissauga, ON, Canada) will be added to the irrigation bottles of the patients.
Drug: Budesonide irrigation
Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline,Month 3,Month 6,Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Olfactory cleft CT score
Time Frame: Baseline,Month 3,Month 6,Month 12
Baseline,Month 3,Month 6,Month 12
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.
Baseline,Month 3,Month 6,Month 12
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.
Baseline,Month 3,Month 6,Month 12
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.
Baseline,Month 3,Month 6,Month 12
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.
Baseline,Month 3,Month 6,Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 14, 2025

Primary Completion (Estimated)

March 14, 2027

Study Completion (Estimated)

March 14, 2027

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9059104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will decide whether to share the individual participant data after the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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