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Status unknownNCT06353139Updated Apr 8, 2024

The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction

An interventional study of Modified olfactory training device in Olfactory Impairment, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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?

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.

02

Conditions studied

  • Olfactory Impairment

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03

In context

Olfaction Disorders

61 studies on the registry are indexed under Olfaction Disorders; 17 are open to participants now.

This study's planned enrollment of 72 is above the median of 60 across 41 interventional studies indexed under Olfaction Disorders.

Browse Olfaction Disorders studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 749 studies on the registry; 270 are open to participants now.

Browse Peking University Third Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    The traditional olfactory training

    Device: Modified olfactory training device

  • Experimental
    The modified olfactory training

    Device: Modified olfactory training device

Interventions

  • DeviceModified olfactory training device

    Conduct olfactory training in patients with olfactory disorders

06

What researchers measure

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)

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Dawei Wu
    Beijing, Beijing Municipality 100191, China
    Recruiting
08

References and documents

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 34456675 ↗
  • 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. PubMed 35373533 ↗

Individual participant data

Plan to share: No — We will decide whether to share the individual participant data after the study.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Dec 2024, 17 months after the start.

Of 18 interventional studies with no phase under Olfaction Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2024
First posted
Apr 8, 2024
StartActual
Jul 1, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Apr 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06353139
Lead sponsor
Peking University Third Hospital
Responsible party
Dawei Wu (Associate Researcher, Peking University Third Hospital) — Principal investigator
First posted
Apr 8, 2024
Start date
Jul 1, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Apr 8, 2024

Study contacts

Dawei Wu, MD, PhD
Contact
davidwuorl@163.com
13522503401

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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