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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The traditional olfactory training | Active Comparator |
| |
| The modified olfactory training | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified olfactory training device | Device | Conduct olfactory training in patients with olfactory disorders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant olfactory improvement | a clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)( more than 6 scores) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawei Wu, MD, PhD | Contact | 13522503401 | davidwuorl@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dawei Wu | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34456675 | Result | 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. | |
| 35373533 | Result | Patel 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. |
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We will decide whether to share the individual participant data after the study.
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| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |