Olfactory ImpairmentNCT06353139
The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction
A study testing Modified olfactory training device in people with Olfactory Impairment, 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 olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Olfactory Impairment
- What is being tested?
- Modified olfactory training device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with olfactory disorder when TDI score was less than 30.75.
- Patients would perform Sniffin' Sticks examination.
- Voluntarily sign the informed consent form
- Able to undergo olfactory training and participate in follow-up visits
Who cannot join
- Smoking
- Combined with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc.
- Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks will be excluded.
- Patients who cannot tolerate olfactory function testing and treatment
- Severe coexisting diseases: such as malignant tumors, life expectancy <2 years
- Patients who are pregnant or planning to become pregnant
- According to the researcher's judgment, the patient is unable to complete this study or cannot comply with the requirements of this study (such as memory or behavioral abnormalities, depression, heavy drinking, past breach of contract)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dawei Wu
Beijing, Beijing Municipality, 100191
Dawei Wu, MD, PhD, 13522503401, davidwuorl@163.com
davidwuorl@163.com
About this study
Official title: Modified Olfactory Training for Patients With Olfactory Disfunction:A Randomized Clinical Trial
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 olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction?
Read the detailed description
Olfactory training is a new therapy that improves olfactory function by exposing patients to various types of odors through regular, repetitive active sniffing. However, there are still many problems with olfactory training in clinical practice, including poor patient adherence, lack of standardized and uniform procedures, and inconvenient carrying of devices.
Now, the investigators have initially developed an olfactory training device based on expiratory pressure, and the advantages of the improved device are as follows: bi-directional airflow, positive pressure and the function of voice prompts and automatic counting.
In this study, the investigators planned to recruit 72 patients and divided them into two groups for olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on the comparison of the outcomes of the two groups.
- Conditions
- Olfactory Impairment
- Being tested
- Modified olfactory training device
- Medical subject headings
- Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified olfactory training deviceDevice
Conduct olfactory training in patients with olfactory disorders
| Study group | Role | What they receive |
|---|---|---|
| The traditional olfactory training | Active comparator | Not described Receives: Device: Modified olfactory training device |
| The modified olfactory training | Experimental | Not described Receives: Device: Modified olfactory training device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant olfactory improvement
a clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification（TDI)( more than 6 scores)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Olfactory ImpairmentStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Participant, Investigator
- Enrolment
- 72 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
- NCT06353139
- Sponsor's protocol ID
- 90591
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 8 Apr 2024
- 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
Yuan F, Huang T, Wei Y, Wu D. Steroids and Olfactory Training for Postviral Olfactory Dysfunction: A Systematic Review. Front Neurosci. 2021 Aug 12;15:708510. doi: 10.3389/fnins.2021.708510. eCollection 2021.
PubMed 34456675Patel ZM, Holbrook EH, Turner JH, Adappa ND, Albers MW, Altundag A, Appenzeller S, Costanzo RM, Croy I, Davis GE, Dehgani-Mobaraki P, Doty RL, Duffy VB, Goldstein BJ, Gudis DA, Haehner A, Higgins TS, Hopkins C, Huart C, Hummel T, Jitaroon K, Kern RC, Khanwalkar AR, Kobayashi M, Kondo K, Lane AP, Lechner M, Leopold DA, Levy JM, Marmura MJ, Mclelland L, Miwa T, Moberg PJ, Mueller CA, Nigwekar SU, O'Brien EK, Paunescu TG, Pellegrino R, Philpott C, Pinto JM, Reiter ER, Roalf DR, Rowan NR, Schlosser RJ, Schwob J, Seiden AM, Smith TL, Soler ZM, Sowerby L, Tan BK, Thamboo A, Wrobel B, Yan CH. International consensus statement on allergy and rhinology: Olfaction. Int Forum Allergy Rhinol. 2022 Apr;12(4):327-680. doi: 10.1002/alr.22929.
PubMed 35373533
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Olfactory Training for Patients With Olfactory Disfunction:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06353139
- Acronym / sponsor ID
- 90591
- Conditions
- Olfactory Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Apr 2024 (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 olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction?
Detailed description
Olfactory training is a new therapy that improves olfactory function by exposing patients to various types of odors through regular, repetitive active sniffing. However, there are still many problems with olfactory training in clinical practice, including poor patient adherence, lack of standardized and uniform procedures, and inconvenient carrying of devices.
Now, the investigators have initially developed an olfactory training device based on expiratory pressure, and the advantages of the improved device are as follows: bi-directional airflow, positive pressure and the function of voice prompts and automatic counting.
In this study, the investigators planned to recruit 72 patients and divided them into two groups for olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on the comparison of the outcomes of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The traditional olfactory training | Active comparator | Device: Modified olfactory training device |
| The modified olfactory training | Experimental | Device: Modified olfactory training device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with olfactory disorder when TDI score was less than 30.75.
- Patients would perform Sniffin' Sticks examination.
- Voluntarily sign the informed consent form
- Able to undergo olfactory training and participate in follow-up visits
Key exclusion criteria (7 listed)
- Smoking
- Combined with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc.
- Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks will be excluded.
- Patients who cannot tolerate olfactory function testing and treatment
- Severe coexisting diseases: such as malignant tumors, life expectancy <2 years
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 |
|---|---|---|
| Modified olfactory training deviceConduct olfactory training in patients with olfactory disorders | Device | The modified olfactory training, The traditional olfactory training |
Primary outcome
Clinically significant olfactory improvement
Time frame: 1 year
a clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification（TDI)( more than 6 scores)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Results publication: PubMed 34456675Yuan F, Huang T, Wei Y, Wu D. Steroids and Olfactory Training for Postviral Olfactory Dysfunction: A Systematic Review. Front Neurosci. 2021 Aug 12;15:708510. doi: 10.3389/fnins.2021.708510. eCollection 2021.
- Results publication: PubMed 35373533Patel ZM, Holbrook EH, Turner JH, Adappa ND, Albers MW, Altundag A, Appenzeller S, Costanzo RM, Croy I, Davis GE, Dehgani-Mobaraki P, Doty RL, Duffy VB, Goldstein BJ, Gudis DA, Haehner A, Higgins TS, Hopkins C, Huart C, Hummel T, Jitaroon K, Kern RC, Khanwalkar AR, Kobayashi M, Kondo K, Lane AP, Lechner M, Leopold DA, Levy JM, Marmura MJ, Mclelland L, Miwa T, Moberg PJ, Mueller CA, Nigwekar SU, O'Brien EK, Paunescu TG, Pellegrino R, Philpott C, Pinto JM, Reiter ER, Roalf DR, Rowan NR, Schlosser RJ, Schwob J, Seiden AM, Smith TL, Soler ZM, Sowerby L, Tan BK, Thamboo A, Wrobel B, Yan CH. International consensus statement on allergy and rhinology: Olfaction. Int Forum Allergy Rhinol. 2022 Apr;12(4):327-680. doi: 10.1002/alr.22929.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified olfactory training device in people with Olfactory Impairment, 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 7 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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. 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. 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?
Results are not available in the source record.
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?
Clinically significant olfactory improvement (time frame: 1 year). 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 NCT06353139, which also lists 2 linked publications.
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 8 Apr 2024.