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An exploratory clinical trial employing a crossover design to evaluate DYS001 and T&T olfactometer with respect to olfactory classification ability

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Patients requiring assessment of olfactory sensitivity
Date of first enrollment	12/03/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Set the dedicated cartridge DYS001 (investigational drug) into olfactory display device (NOS-DX1000) of Sony Group Corporation, following the insruction manuals of device. Prepare a new nose guide for each subject, and set it in the mounting section of NOS-DX1000. Turn on both NOS-DX1000 and the tablet, and check the connection between them. DYS001 is filled with five types of bromine solutions, and each bromine solution is prepared in six concentration levels - 5, 4, 3, 2, 1, and 0 - where level 5 is the highest concentration, and each subsequent level represents a tenfold dilution from the previous one. However, due to the solubility of B, it is impossible to adjust the concentration of B5, resulting in a five-step concentration scale up to B4. (A) Phenylethyl alcohol (the smell of rose, ligth and sweet smell) (B) Methylcyclopentenolone (a burnt smell, caramel smell)(C) Isovaleric acid (a putrid smell, the smell of old socks, sweaty smell, the smell of natto) (D) gamma Undecalactone (the smell of canned peaches, sweet and heavy smell) (E) Skatole (the smell of feces, the smell of vegetable wastes, halitosis, bad smell) The order for smelling bromine solutions is to start with A, followed by B, C, D, and E. Start with the lowest concentration of 0 and gradually increase the odor intensity. When the subject first perceive a smell (detection threshold), select circle symbol on the tablet at the corresponding concentration. Next, check whether they can identify what the smell is or what it is like. If they still can not identify it, have them smell a stronger bromine solution, increasing the strength step by step until they can recognize it. The subject selects cross symbol at the point (perception threshold) when subject provides the correct answer or a close expression.

Outcome(s)

Primary Outcome	Evaluation of the agreement rates of olfactory grades using the kappa coefficient
Secondary Outcome	Efficacy: average perception threshold Safety: adverse events, side effects, etc.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Subjects who satisfy all of the following criteria will be included. (1)Individuals aged 18 years or older, from whom written informed consent has been obtained. (2)Patients requiring olfactory sensitivity assessment, or patients whose olfactory grade has already been determined. (3)Patients who are capable of appropriately conducting the assessments specified in this clinical trial and obtaining both perception and detection thresholds.
Exclude criteria	Subjects who satisfy any of the following criteria will be excluded. (1) Patients participating in another clinical trial (including follow-up). (2) Patients who have previously undergone olfactory testing in a clinical trial of DYS001. (3) Patients diagnosed solely with qualitative olfactory disorders (parosmia, olfactory blindness, etc.) (4) Patients diagnosed with cognitive impairment or severe depression. (5) Patients who are pregnant or plan to become pregnant during the clinical trial period. (6) Patients whom principal investigator (sub-investigator) determines to be inappropriate for participation in the clinical trial.