The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction

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?

Study Overview

• Status: Recruiting
• Conditions: Olfactory Impairment
• Intervention / Treatment: Device: Modified olfactory training device

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dawei Wu, MD, PhD; Phone Number: 13522503401; Email: davidwuorl@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Dawei Wu
      • Contact: Dawei Wu, MD, PhD; Phone Number: 13522503401; Email: davidwuorl@163.com
      • Contact: Email: davidwuorl@163.com
      • Principal Investigator: Dawei Wu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients diagnosed with olfactory disorder when TDI score was less than 30.75.
2. Patients would perform Sniffin' Sticks examination.
3. Voluntarily sign the informed consent form
4. Able to undergo olfactory training and participate in follow-up visits

Exclusion Criteria:

1. Smoking
2. Combined with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc.
3. Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks will be excluded.
4. Patients who cannot tolerate olfactory function testing and treatment
5. Severe coexisting diseases: such as malignant tumors, life expectancy <2 years
6. Patients who are pregnant or planning to become pregnant
7. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The traditional olfactory training	Device: Modified olfactory training device; Conduct olfactory training in patients with olfactory disorders
Experimental: The modified olfactory training	Device: Modified olfactory training device; Conduct olfactory training in patients with olfactory disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Publications and helpful links

General 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.
• 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. Erratum In: Int Forum Allergy Rhinol. 2023 Sep;13(9):1844.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders
• Other Study ID Numbers: 90591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will decide whether to share the individual participant data after the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No