Olfactory DysfunctionNCT06829706
The Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction
A study testing Conventional olfactory training device and Modified olfactory training device in people with Olfactory Dysfunction and Post Viral Olfactory Dysfunction (PVOD), 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 the modified olfactory training device effective in treating patients with post-viral olfactory dysfunction? Compared to the conventional device, how efficient is the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Olfactory Dysfunction, Post Viral Olfactory Dysfunction (PVOD)
- What is being tested?
- Conventional olfactory training device and Modified olfactory training device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2025to 22 May 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
- Age 18-80 years old, gender not limited.
- Patients diagnosed with olfactory dysfunction following infections of the upper respiratory tract, as determined by Sniffin' Sticks test (including TDI value test).
- Voluntarily signs the informed consent form.
Who cannot join
- Patients with post-traumatic olfactory dysfunction, rhinosinusitis-related dysfunction and olfactory dysfunction caused by other reasons.
- Patients with concomitant sinonasal disease.
- Patients with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc.
- Patients with serious coexisting diseases: such as malignant tumors, etc., with a life expectancy of less than 2 years.
- Patients who cannot tolerate olfactory function testing and treatment.
- Patients who have taken oral glucocorticoids, antibacterial drugs, anti-leukotrienes, antihistamines, or received olfactory training within four weeks will be excluded.
Show all 11Show fewer
- Patients who are receiving treatment that affects olfactory recovery.
- Patients with smoking habits.
- Patients who are already or plan to be pregnant.
- According to the judgment of the researchers, the patient cannot complete this study or cannot comply with the requirements of this study (such as memory or behavior abnormalities, depression, heavy drinking, previous breach of contract).
- Patients who did not consent for participating in the study.
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, 1 recruiting
- Recruiting
Bejing
Beijing, 100191
Dawei Wu, MD, PhD, 13522503401, davidwuorl@163.com
About this study
Official title: A Randomized Trail Protocol to Access Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction
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 the modified olfactory training device effective in treating patients with post-viral olfactory dysfunction? Compared to the conventional device, how efficient is the modified olfactory training device for improving olfactory function?
Read the detailed description
Background The aim of this article is to present the research protocol for a randomized, controlled, multi-center, placebo study that will assess the olfactory function and the effect of an intervention based on olfactory training in patients with post-viral olfactory dysfunction, and compare it with traditional olfactory training. The sample selection will follow the multi-center principle. The olfactory training (OT) intervention will last for 12 weeks.
Evaluation The primary endpoint will be the change in olfactory ability from baseline to the 12-week intervention or control period. The intervention effect will be evaluated by the total score of the Sniffer Stick Test (SST)-Threshold, Discrimination and Identification (TDI)-Extended Version. Secondary endpoints will be changes in olfactory bulb volume and shape, olfactory-related brain area volume, olfactory and trigeminal nerve-related potentials, and cognitive questionnaires.
Conclusion（objective） The present study aimed to explore the efficacy of the modified olfactory training device (MOT), and compare COT and MOT with respect to the resultant improvement in olfactory function.
At the same time, our study will use a variety of outcome indicators to evaluate the changes in patients before and after treatment, which will lay the foundation for exploring the mechanism of olfactory training in treating patients with post-viral olfactory disorders.
- Being tested
- Conventional olfactory training device, Modified olfactory training device, Conventional olfactory training device with placebo
- Keywords
- Olfactory Training, Modified Olfactory Training Device, Post Viral Olfactory Dysfunction (PVOD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional olfactory training deviceDevice
Conventional olfactory training was designed by Hummel et al. They performed OT using four odors (phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronella, lemon; and eugenol, cloves), which are representative of four odor categories on the odor prism proposed by Henning.
Modified olfactory training deviceDevice
Participants will use a modified olfactory training device based on expiratory pressure. Its bidirectional airflow and unidirectional pressure characteristics significantly increased the deposition rate of olfactory odors in the olfactory cleft area, making the patient feel stronger in the nasal cavity during olfactory training.
Conventional olfactory training device with placeboDevice
Based on the traditional olfactory training device, four olfactory odors are replaced by placebo。
| Study group | Role | What they receive |
|---|---|---|
| The Conventional olfactory training | Active comparator | Patients allocated to the COT group are told to expose themselves twice daily to four odors (phenyl ethyl alcohol: rose, menthol: mint, citronellal: lemon, and eugenol: cloves)，which are placed in four brown glass jars (total volume 50 mL) with one of the four odors in each (1 mL each, soaked in cotton pads to prevent spilling). All jars are labeled with the odor name.
Olfactory training includes exposure to odorants twice per day for 5 minutes. Every olfactory session included rotated exposure to each odorant for 10 seconds each, with time intervals of 10 seconds between odors. The resting order of the four odors is mint-rose-lemon-clove.
Patients were advised to sniff the odors in the morning before breakfast and in the evening before bedtime. Receives: Device: Conventional olfactory training device |
| The Control group | Sham comparator | The COT group will differ solely with regard to the ingredients contained in the training jars given to the participants. Whereas in the COT group, the training jars will contain the active odors previously selected, in the placebo group, the training jars will be filled with a placebo odorless solvent (propylene glycol). To increase the overall compliance and to ascertain that the placebo (odorless) group remains blinded to the treatment allocation, all patients are told that whereas the odors used during the therapy tend to be less strong, and may be insufficiently intense to produce an odor sensation (i.e., subliminal odors), they are intense enough to be perceived by the brain and may influence mental processes and behavior. The training will last for 12 weeks. After the study completion, all participants will be individually contacted and their group allocations will be revealed. All patients will be offered the possibility of performing or continuing a training with odors. Receives: Device: Conventional olfactory training device with placebo |
| The Modified olfactory training | Experimental | When the patient is doing olfactory training, he/she selects an odor and installs the corresponding odor bottle on the new olfactory training device. Insert the nose end into one nostril, hold the mouth end in the mouth, take a deep breath through the nose, blow out slowly for about 7 seconds, and carefully experience the changes in the nature and intensity of the nasal odor. Immediately remove the device from the nostril and mouth, take a slow, natural breath through the nose for about 3 seconds; Repeat the above operation for a total of three cycles. The operation steps for the other nostril are the same as those above. When both nostrils have finished sniffing the same odor, stop the training, breathe freely, and rest for 10 seconds. Then continue to sniff the next odor and train in the order and method described above.
Accordingly, all odors used for the application of MOT were identical to the COT method in terms of the duration and application time of each session. Receives: Device: Modified olfactory training device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total scores in the "Sniffin 'Sticks" test
This olfactory test consists of three subtests that respectively measure odor threshold (T), odor discrimination (D), and odor identification (I). Each subtest has a maximum score of 16, and the sum of the scores from the three subtests provides the global olfactory score (TDI score; Threshold, Discrimination, Identification) with a maximum of 48 points. Patients with a TDI composite score≥30.5 are defined as normosmic. In contrast, those with a TDI composite score between 16.5 and 30.5 are defined as hyposmic, and patients with a TDI composite score<16.5 are defined as functionally anosmic. Based on previous literature, we have established a 5.5 points improvement in the TDI composite score as a significant change.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Secondary outcomes (7)
OB volume and shape measurement
OB volumetric evaluations will be performed with a 3-Tesla MRI system with coronal T2-weighted fast spin-echo images that included the anterior and the middle parts of the skull base.
The OB volume will be measured using manual segmentation. The contours of the left and the right OBs will be manually delineated. The proximal limit of the OB will be determined on the basis of the sudden change in the diameter at the beginning of the olfactory tract. After all surfaces are added and multiplied by the slice thickness, the volume in cubic millimeters will be obtained for the right and the left OBs, and the total OB volume will be calculated as the sum of the two values.
Measurements will be performed blindly twice by two examiners. When the difference in volume is > 10%, the examiners will perform a third measurement together.
We have interpreted oval, round, triangular, and bean/boat/banana shapes as normal variants of OB shape.Atrophy will be interpreted as flattened OB.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
MRI volumetric evaluation related to GM
Magnetic resonance imaging (MRI) scans will be performed on a 3T Siemens Verio scanner with a 12-channel phased-array head coil,measuring gray matter(GM) volumes to explore the connection between olfactory function and brain regions.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
MRI volumetric evaluation related to WM
Magnetic resonance imaging (MRI) scans will be performed on a 3T Siemens Verio scanner with a 12-channel phased-array head coil,measuring white matter(WM) volumes to explore the connection between olfactory function and brain regions.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
MRI volumetric evaluation related to CSF
Magnetic resonance imaging (MRI) scans will be performed on a 3T Siemens Verio scanner with a 12-channel phased-array head coil,measuring cerebrospinal fluid(CSF) volumes to explore the connection between olfactory function and brain regions.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Event-related potentials (ERPs)
Event-related potentials include olfactory event-related potentials(oERPs) and trigeminal event-related potentials (tERPs).
We will use an OM6b olfactometer to generate ERPs after we have stimulated patients with phenethyl alcohol per standard methods.We infuse olfactory- and then trigeminal-nerve stimuli into the nasal cavity at a constant temperature and flow rate.We will place reference electrodes in the left and right earlobes When analyzing the records offline, we will exclude those contaminated by blinking or other interference . After amplification and filtering, we will obtain stable oERPs and tERPs waveforms.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Questionnaire of Olfactory Disorders
Questionnaire of Olfactory Disorders (QOD) determines the impact of olfactory dysfunction on daily life (70). The QOD consists of 52 statements, which can be divided into 3 domains: 39 negative statements (degree of suffering; NS), 5 positive statements (positive effects and coping strategies) and 8 socially desired statements ("lie scale") .
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Visual analogue scale for olfactory training
Subjective ratings of olfactory function will be also recorded at baseline and follow-up appointments by means of a visual analogue scale, scoring from 0 to 100. On this scale, 0 represents complete olfactory loss and 100 perfect olfactory function. In addition, patients were asked about the presence of qualitative olfactory disorders such as parosmia.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start22 Mar 2025 (estimated)
- Primary completion22 Mar 2027 (estimated)
- Study completion22 May 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 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
- NCT06829706
- Sponsor's protocol ID
- 9059103
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 17 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
Xie J, Li Y, He H, Liu Y, Chen L, Liu X, Zhao D, Wu D. Randomised trial protocol to assess efficacy of modified olfactory training method for patients with postinfectious olfactory dysfunction. BMJ Open. 2025 Dec 23;15(12):e101183. doi: 10.1136/bmjopen-2025-101183.
PubMed 41436263
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trail Protocol to Access Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction
- ClinicalTrials.gov ID
- NCT06829706
- Acronym / sponsor ID
- 9059103
- Keywords
- Olfactory Training, Modified Olfactory Training Device, Post Viral Olfactory Dysfunction (PVOD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 Mar 2025 (estimated)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 May 2027 (estimated)
- First posted
- 17 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 the modified olfactory training device effective in treating patients with post-viral olfactory dysfunction? Compared to the conventional device, how efficient is the modified olfactory training device for improving olfactory function?
Detailed description
Background The aim of this article is to present the research protocol for a randomized, controlled, multi-center, placebo study that will assess the olfactory function and the effect of an intervention based on olfactory training in patients with post-viral olfactory dysfunction, and compare it with traditional olfactory training. The sample selection will follow the multi-center principle. The olfactory training (OT) intervention will last for 12 weeks.
Evaluation The primary endpoint will be the change in olfactory ability from baseline to the 12-week intervention or control period. The intervention effect will be evaluated by the total score of the Sniffer Stick Test (SST)-Threshold, Discrimination and Identification (TDI)-Extended Version. Secondary endpoints will be changes in olfactory bulb volume and shape, olfactory-related brain area volume, olfactory and trigeminal nerve-related potentials, and cognitive questionnaires.
Conclusion（objective） The present study aimed to explore the efficacy of the modified olfactory training device (MOT), and compare COT and MOT with respect to the resultant improvement in olfactory function.
At the same time, our study will use a variety of outcome indicators to evaluate the changes in patients before and after treatment, which will lay the foundation for exploring the mechanism of olfactory training in treating patients with post-viral olfactory disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Conventional olfactory training | Active comparator | Device: Conventional olfactory training devicePatients allocated to the COT group are told to expose themselves twice daily to four odors (phenyl ethyl alcohol: rose, menthol: mint, citronellal: lemon, and eugenol: cloves)，which are placed in four brown glass jars (total volume 50 mL) with one of the four odors in each (1 mL each, soaked in cotton pads to prevent spilling). All jars are labeled with the odor name. Olfactory training includes exposure to odorants twice per day for 5 minutes. Every olfactory session included rotated exposure to each odorant for 10 seconds each, with time intervals of 10 seconds between odors. The resting order of the four odors is mint-rose-lemon-clove. Patients were advised to sniff the odors in the morning before breakfast and in the evening before bedtime. |
| The Control group | Sham comparator | Device: Conventional olfactory training device with placeboThe COT group will differ solely with regard to the ingredients contained in the training jars given to the participants. Whereas in the COT group, the training jars will contain the active odors previously selected, in the placebo group, the training jars will be filled with a placebo odorless solvent (propylene glycol). To increase the overall compliance and to ascertain that the placebo (odorless) group remains blinded to the treatment allocation, all patients are told that whereas the odors used during the therapy tend to be less strong, and may be insufficiently intense to produce an odor sensation (i.e., subliminal odors), they are intense enough to be perceived by the brain and may influence mental processes and behavior. The training will last for 12 weeks. After the study completion, all participants will be individually contacted and their group allocations will be revealed. All patients will be offered the possibility of performing or continuing a training with odors. |
| The Modified olfactory training | Experimental | Device: Modified olfactory training deviceWhen the patient is doing olfactory training, he/she selects an odor and installs the corresponding odor bottle on the new olfactory training device. Insert the nose end into one nostril, hold the mouth end in the mouth, take a deep breath through the nose, blow out slowly for about 7 seconds, and carefully experience the changes in the nature and intensity of the nasal odor. Immediately remove the device from the nostril and mouth, take a slow, natural breath through the nose for about 3 seconds; Repeat the above operation for a total of three cycles. The operation steps for the other nostril are the same as those above. When both nostrils have finished sniffing the same odor, stop the training, breathe freely, and rest for 10 seconds. Then continue to sniff the next odor and train in the order and method described above. Accordingly, all odors used for the application of MOT were identical to the COT method in terms of the duration and application time of each session. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years old, gender not limited.
- Patients diagnosed with olfactory dysfunction following infections of the upper respiratory tract, as determined by Sniffin' Sticks test (including TDI value test).
- Voluntarily signs the informed consent form.
Key exclusion criteria (11 listed)
- Patients with post-traumatic olfactory dysfunction, rhinosinusitis-related dysfunction and olfactory dysfunction caused by other reasons.
- Patients with concomitant sinonasal disease.
- Patients with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc.
- Patients with serious coexisting diseases: such as malignant tumors, etc., with a life expectancy of less than 2 years.
- Patients who cannot tolerate olfactory function testing and treatment.
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 deviceConventional olfactory training was designed by Hummel et al. They performed OT using four odors (phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronella, lemon; and eugenol, cloves), which are representative of four odor categories on the odor prism proposed by Henning. | Device | The Conventional olfactory training |
| Modified olfactory training deviceParticipants will use a modified olfactory training device based on expiratory pressure. Its bidirectional airflow and unidirectional pressure characteristics significantly increased the deposition rate of olfactory odors in the olfactory cleft area, making the patient feel stronger in the nasal cavity during olfactory training. | Device | The Modified olfactory training |
| Conventional olfactory training device with placeboBased on the traditional olfactory training device, four olfactory odors are replaced by placebo。 | Device | The Control group |
Primary outcome
The total scores in the "Sniffin 'Sticks" test
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
This olfactory test consists of three subtests that respectively measure odor threshold (T), odor discrimination (D), and odor identification (I). Each subtest has a maximum score of 16, and the sum of the scores from the three subtests provides the global olfactory score (TDI score; Threshold, Discrimination, Identification) with a maximum of 48 points. Patients with a TDI composite score≥30.5 are defined as normosmic. In contrast, those with a TDI composite score between 16.5 and 30.5 are defined as hyposmic, and patients with a TDI composite score<16.5 are defined as functionally anosmic. Based on previous literature, we have established a 5.5 points improvement in the TDI composite score as a significant change.
7 secondary outcomes
OB volume and shape measurement
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
MRI volumetric evaluation related to GM
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
MRI volumetric evaluation related to WM
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
MRI volumetric evaluation related to CSF
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
Event-related potentials (ERPs)
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
Questionnaire of Olfactory Disorders
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
Visual analogue scale for olfactory training
Time frame: Baseline,Month 3,Month 6,Month 12,Month 24
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 17 Feb 2025.
- Derived from this study: PubMed 41436263Xie J, Li Y, He H, Liu Y, Chen L, Liu X, Zhao D, Wu D. Randomised trial protocol to assess efficacy of modified olfactory training method for patients with postinfectious olfactory dysfunction. BMJ Open. 2025 Dec 23;15(12):e101183. doi: 10.1136/bmjopen-2025-101183.
- Individual participant dataSharing planned: No. We will decide whether to share the individual participant data after the study.
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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 and Modified olfactory training device in people with Olfactory Dysfunction and Post Viral Olfactory Dysfunction (PVOD), 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 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 total scores in the "Sniffin 'Sticks" test (time frame: Baseline,Month 3,Month 6,Month 12,Month 24). 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 NCT06829706, 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 17 Feb 2025.