An interventional study of Conventional olfactory training device and Modified olfactory training device in Olfactory Dysfunction and Chronic Rhinosinusitis, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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?
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.
251 studies on the registry are indexed under Rhinosinusitis; 69 are open to participants now.
This study's planned enrollment of 213 is above the median of 74 across 177 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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 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 can effectively target the olfactory cleft area to provide anti-inflammatory effects.
The Sniffin's Sticks test
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)( more than 6 scores)
Time frame: Baseline,Month 3,Month 6,Month 12
Olfactory cleft CT score
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline,Month 3,Month 6,Month 12
Plan to share: No — We will decide whether to share the individual participant data after the study.
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Mar 2027, 24 months later.
Of 33 interventional studies with no phase under Rhinosinusitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 24 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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