Patients requiring assessment of olfactory sensitivity
Conditions
Interventions
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
Sponsors
Miwa Takaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the agreement rates of olfactory grades using the kappa coefficient | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: average perception threshold Safety: adverse events, side effects, etc. | — |
Contacts
Public Contactinquiry desk for JRCT intellim
intellim Corporation
Outcome results
None listed