The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Visual-OLfactory Training in Participants With COVID-19 Resultant Loss of Smell

NCT04710394

Anosmia Covid19 Ageusia +4 more

COMPLETED NA

Treatment of Olfactory Dysfunction Using Vagus Nerve Stimulation

NCT06817499

Hyposmia

ACTIVE_NOT_RECRUITING NA

ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

NCT04445597

SARS-CoV-2

UNKNOWN NA

Oral Vasopressin Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study

NCT06329063

Healthy

RECRUITING NA

The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study

NCT06329037

Healthy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Olfactory Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The traditional olfactory training

Group Type ACTIVE_COMPARATOR

Modified olfactory training device

Intervention Type DEVICE

Conduct olfactory training in patients with olfactory disorders

The modified olfactory training

Group Type EXPERIMENTAL

Modified olfactory training device

Intervention Type DEVICE

Conduct olfactory training in patients with olfactory disorders

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modified olfactory training device

Conduct olfactory training in patients with olfactory disorders

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes