The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction

NCT06353139 | Recruiting DMC

• 1 other identifier: 90591
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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 treating patients with olfactory disfunction?

Conditions

Olfactory Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The traditional olfactory training

ACTIVE COMPARATOR

Device: Modified olfactory training device

The modified olfactory training

EXPERIMENTAL

Device: Modified olfactory training device

Interventions

Modified olfactory training device DEVICE

Conduct olfactory training in patients with olfactory disorders

The modified olfactory training; The traditional olfactory training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Dawei Wu

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 34456675 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.

  PMID: 35373533 RESULT

MeSH Terms

Conditions

Olfaction Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dawei Wu, MD, PhD

CONTACT

13522503401; davidwuorl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 8, 2024
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)