Randomised trial protocol to assess efficacy of modified olfactory training method for patients with postinfectious olfactory dysfunction.
Jiatong Xie, Yankun Li, Hong He...
https://pubmed.ncbi.nlm.nih.gov/41436263Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06829706
Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction: A Randomized Controlled Trial
Led by Peking University Third Hospital · Updated on 2025-02-17
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a modified olfactory training device for treating patients with post-viral olfactory dysfunction. This trial aims to compare how well the modified device works versus the traditional olfactory training device. The study will use various measures to assess changes in smell function and brain-related changes over time to better understand how olfactory training helps these patients. Participants are divided into three groups: one group uses the conventional olfactory training device with active odors, another uses a placebo device with odorless solution, and the third uses the modified olfactory training device designed to improve odor delivery through bidirectional airflow and pressure. Training involves smelling four specific odors twice daily for 5 minutes each session over 12 weeks. Each odor is sniffed in a structured sequence with rest intervals. During the study, participants will be assessed at baseline and at multiple follow-up points up to 24 months. Tests include the Sniffin’ Sticks test to measure smell ability, MRI scans to evaluate brain and olfactory bulb changes, nerve-related potentials, and questionnaires about smell disorders. Researchers will also monitor training adherence and safety. After completing the study, participants will be informed about their group and offered the option to continue odor training.
CONDITIONS
Brief Title
The Efficacy of Modified Olfactory Training Method for Patients With Post-viral Olfactory Dysfunction
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18-80 years old, any gender
- Diagnosed with olfactory dysfunction after upper respiratory tract infection confirmed by Sniffin' Sticks test
- Voluntarily signs informed consent form
You will not qualify if you...
- Olfactory dysfunction caused by trauma, rhinosinusitis, or other reasons
- Presence of sinonasal disease
- Chronic diseases such as hypertension, diabetes, bronchopneumonia, or chronic obstructive pulmonary disease
- Serious diseases like malignant tumors with life expectancy under 2 years
- Unable to tolerate olfactory testing or treatment
- Use of oral glucocorticoids, antibacterial drugs, anti-leukotrienes, antihistamines, or olfactory training within last 4 weeks
- Receiving treatment affecting olfactory recovery
- Smoking habits
- Currently pregnant or planning pregnancy
- Unable to comply with study requirements due to memory, behavior, or other issues
- Did not consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 12 weeks
Participants use either a conventional, modified, or placebo olfactory training device to perform olfactory training twice daily. Each training session lasts about 5 minutes and involves exposure to four different odors or odorless placebo, depending on group assignment. This training aims to improve olfactory function over a 12-week period.
Twice daily training sessions at home
Follow-up
Duration - Up to 24 months post-baseline
Participants undergo evaluations to assess changes in olfactory function, olfactory bulb and brain volumes, nerve-related potentials, and cognitive questionnaires at multiple time points following the intervention.
Visits at Month 3, Month 6, Month 12, and Month 24
Trial Site Locations
Total: 1 location
1
Bejing
Beijing, China, 100191
Actively Recruiting
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Research Team
D
Dawei Wu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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