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

NCT06837051 | Not Yet Recruiting DMC

• 1 other identifier: 9059104
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Olfactory Dysfunction; Chronic Rhinosinusitis

Keywords

olfactory dysfunction; chronic rhinosinusitis; endoscopic sinus surgery; olfactory training

Outcome Measures

Primary Outcomes (1)

• The Sniffin's Sticks test

  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 Outcomes (5)

• Olfactory cleft CT score

  Baseline,Month 3,Month 6,Month 12

• Olfactory cleft endoscopy scale (OCES)

  Baseline,Month 3,Month 6,Month 12

• OB volume measurement

  Baseline,Month 3,Month 6,Month 12

• Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)

  Baseline,Month 3,Month 6,Month 12

• Olfactory-Visual Analogue Scale (VAS)

  Baseline,Month 3,Month 6,Month 12

Study Arms (3)

The Conventional Olfactory Training Group

ACTIVE COMPARATOR

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

The Modified Olfactory Training Group

EXPERIMENTAL

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 Control Group

SHAM COMPARATOR

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

Interventions

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.

The Conventional Olfactory Training Group

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.

The Modified Olfactory Training Group

Budesonide irrigation DRUG

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

The Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Beijing

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

• Li Y, Li Y, Zhang Y, Wu D. Protocol for a randomised controlled trial evaluating the effect of modified olfactory training on postoperative olfactory dysfunction in patients with CRS. BMJ Open. 2025 Aug 16;15(8):e101870. doi: 10.1136/bmjopen-2025-101870.

  PMID: 40819876 DERIVED

Central Study Contacts

Dawei Wu, MD, PhD

CONTACT

13522503401; davidwuorl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 20, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): March 14, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)