Investigating the effects of 16-item olfactory training (Modified Olfactory Training) in improving olfactory disorders

This study aims to compare the effectiveness of a 16-item Modified Olfactory Training protocol against classic training and a placebo for treating post-viral smell loss. It will measure improvements in odor identification, discrimination, and threshold to develop better rehabilitation strategies for patients.

A single-center, randomized, single-blind, three-arm parallel-group controlled trial with a total sample size of 60 participants. Randomization will be computer-generated with allocation concealment, comparing modified olfactory training (16 scents), classic training (4 fixed scents), and placebo control groups over a 16-week intervention period.

A single-center, randomized, single-blind trial with 60 participants experiencing l smell loss. Participants are randomly assigned to classic training (4 fixed scents), or modified training (16 rotating scents). Olfactory performance, measured via Sniffin' Sticks test, is assessed at baseline and after a 16-week intervention.

Participants (n=60) with confirmed post-viral olfactory dysfunction. Inclusion requires confirmed smell loss and age 18-50, while exclusion criteria include nasal deformities, neurological/psychiatric conditions, tumors, and other factors that could interfere with the study.

Group 1: Control (Placebo) 20 participants using odorless solvents Group 2: Classic Olfactory Training 20 participants using four fixed scents Group 3: Modified Olfactory Training 20 participants using rotating scents

The main findings of this study pertain to changes in olfactory performance, which are measured using the Sniffin' Sticks test. The primary outcome variables are the scores of this test, evaluated at baseline and after the 16-week intervention.

Participants (n=60) who meet the inclusion criteria will be randomly assigned into three groups (20 patients per group): Group 1 (Control): No olfactory training / placebo kit. Group 2 (Classical Training): 16-week olfactory training with 4 fixed odorants. Group 3 (Modified Training): 16-week olfactory training with 4 different odorants each month. Randomization will be performed using a computer-generated random number table to ensure equal allocation to each group. Allocation concealment will be maintained by assigning codes to participants until group assignment is finalized.

The investigators who provide the training kits will be aware of the allocation due to the differences in kit content. The outcome assessor conducting the Sniffin’s Sticks test will remain blinded to the participants’ group allocation to ensure unbiased evaluation.

Investigating the effects of 16-item olfactory training (Modified Olfactory Training) in improving olfactory disorders". Details of Data to be Shared: Content: All collected de-identified IPD that underlies the results reported in the primary and secondary publications. Specific datasets include: Baseline Characteristics: Age, sex, duration of olfactory loss prior to study entry. Primary Outcome Data: Raw and calculated TDI scores (Threshold, Discrimination, Identification, Total) from the Sniffin' Sticks test at Baseline and Week 16. Group Allocation: The study group each participant was assigned to (Control, Classic OT, Modified OT). Adherence/Compliance Data: Metric of protocol adherence (e.g., percentage of training sessions completed, if collected). Data will be stripped of all direct identifiers: Name, initials, exact birth date, medical record number, contact information, and any other unique identifying details will be removed. A unique, random participant code will be used.

The de-identified Individual Participant Data (IPD), study protocol, statistical analysis plan, and informed consent form will become publicly available no later than the publication date of the primary results manuscript in a peer-reviewed scientific journal. If required by the journal or funder, the data will be deposited at the time of manuscript submission, with the access link becoming active upon article publication.

De-identified Individual Participant Data (IPD) and supporting documents will be made available to any legitimate researcher or analyst, regardless of their institutional affiliation, for the purpose of advancing scientific and public health knowledge. This explicitly includes: Academic Researchers: Researchers and students from universities and other academic institutions. Commercial or Industry Researchers: Researchers working within pharmaceutical, biotechnology, or medical device companies. Government and Public Health Researchers: Researchers from public health agencies, regulatory bodies, or government institutes. Independent Researchers: Qualified researchers not affiliated with a formal institution. Systematic Reviewers and Meta-Analysts: Individuals conducting evidence syntheses.

Purpose: Requests must be for scientific research, such as meta-analysis, validation, or secondary analysis, aligned with ethical standards and the original informed consent. Mechanism: Requestors must submit a formal research proposal outlining objectives, methodology, and intended use. Proposals will be reviewed by a Data Access Committee (including the Principal Investigator and independent members). Conditions: Users must sign a Data Use Agreement prohibiting re-identification, commercial exploitation, or unethical use. Data will be provided securely after approval. Review Criteria: Proposals are evaluated for scientific merit, ethical compliance, feasibility, and alignment with participant consent.

Contact Person: The first point of contact for all data access requests is the Principal Investigator (PI) of the study. Contact Information: Name: Dr. Rafieeh Alizadeh (رفیعه علیزاده) Affiliation: Independent Sensory Health Research Institute, Iran University of Medical Sciences Email: [PI's specific email address would be listed here, e.g., alizadeh.r@iums.ac.ir] Telephone: [+98 21 8670 2508] (University switchboard; request extension for the PI's office or department)

Step-by-Step Process: Initial Inquiry Action: Email the Principal Investigator (PI) with a brief description of your research intent. Time: ~1 week for initial response and receipt of application forms. Formal Application Action: Submit a detailed research proposal and completed Data Access Request Form to the PI. Requirements: Include research objectives, analysis plan, needed variables, and team qualifications. Time: ~1-2 weeks for preparation and submission. Committee Review Action: The Data Access Committee (DAC) reviews the proposal for: Scientific merit and feasibility. Ethical alignment with original consent. Re-identification risks. Time: ~2-4 weeks for assessment and decision. Agreement Execution Action: If approved, sign a Data Use Agreement (DUA) prohibiting re-identification or commercial use. Time: ~1-2 weeks for signing and returning the DUA. Data Transfer Action: Data is shared via a secure repository or encrypted platform. Time: ~1 week for access provisioning.