Olfactory DysfunctionNCT06837051
The Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With CRS
A study testing Conventional olfactory training device, Modified olfactory training device and Budesonide irrigation in people with Olfactory Dysfunction and Chronic Rhinosinusitis, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Olfactory Dysfunction, Chronic Rhinosinusitis
- What is being tested?
- Conventional olfactory training device, Modified olfactory training device and Budesonide irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2025to 14 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing
Beijing, Beijing Municipality, 100191
Dawei Wu, MD, PhD, 13522503401, davidwuorl@163.com
About this study
Official title: 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?
Read the 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.
- Conditions
- Olfactory Dysfunction, Chronic Rhinosinusitis
- Being tested
- Conventional olfactory training device, Modified olfactory training device, Budesonide irrigation
- Keywords
- olfactory dysfunction, chronic rhinosinusitis, endoscopic sinus surgery, olfactory training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional olfactory training deviceDevice
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 deviceDevice
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 irrigationDrug
Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Budesonide irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sniffin's Sticks test
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)( more than 6 scores)
Measured: Baseline,Month 3,Month 6,Month 12
Secondary outcomes (5)
Olfactory cleft CT score
Measured: Baseline,Month 3,Month 6,Month 12
Olfactory cleft endoscopy scale (OCES)
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.
Measured: Baseline,Month 3,Month 6,Month 12
OB volume measurement
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.
Measured: Baseline,Month 3,Month 6,Month 12
Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)
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.
Measured: Baseline,Month 3,Month 6,Month 12
Olfactory-Visual Analogue Scale (VAS)
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.
Measured: Baseline,Month 3,Month 6,Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start14 Mar 2025 (estimated)
- Primary completion14 Mar 2027 (estimated)
- Study completion14 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Olfactory DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawei Wu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837051
- Sponsor's protocol ID
- 9059104
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will decide whether to share the individual participant data after the study.
Publications
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.
PubMed 40819876
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomized Controlled Trial Evaluating the Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT06837051
- Acronym / sponsor ID
- 9059104
- Conditions
- Olfactory Dysfunction, Chronic Rhinosinusitis
- Keywords
- olfactory dysfunction, chronic rhinosinusitis, endoscopic sinus surgery, olfactory training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 14 Mar 2025 (estimated)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 14 Mar 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Conventional Olfactory Training Group | Active comparator | Device: Conventional olfactory training devicePatients 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. |
| The Modified Olfactory Training Group | Experimental | Device: Modified olfactory training devicePatients 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. |
| The Control Group | Sham comparator | Drug: Budesonide irrigationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional olfactory training deviceFour 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. | Device | The Conventional Olfactory Training Group |
| Modified olfactory training deviceThe 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. | Device | The Modified Olfactory Training Group |
| Budesonide irrigationBudesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects. | Drug | The Control Group |
Primary outcome
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)
5 secondary outcomes
Olfactory cleft CT score
Time frame: Baseline,Month 3,Month 6,Month 12
Olfactory cleft endoscopy scale (OCES)
Time frame: Baseline,Month 3,Month 6,Month 12
OB volume measurement
Time frame: Baseline,Month 3,Month 6,Month 12
Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)
Time frame: Baseline,Month 3,Month 6,Month 12
Olfactory-Visual Analogue Scale (VAS)
Time frame: Baseline,Month 3,Month 6,Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 40819876Li 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.
- Individual participant dataSharing planned: No. We will decide whether to share the individual participant data after the study.
Related trials for Olfactory Dysfunction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional olfactory training device, Modified olfactory training device and Budesonide irrigation in people with Olfactory Dysfunction and Chronic Rhinosinusitis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawei Wu, MD, PhD (13522503401, davidwuorl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sniffin's Sticks test (time frame: Baseline,Month 3,Month 6,Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.