Impact of Smell Testing on Health Outcomes

Validating the Impact of Smell Testing on Health Outcomes and Provider Engagement.

Smell dysfunction is frequent yet neglected. The sense of smell plays a crucial role in signaling disease, safety, and overall quality of life. However, the significance of a functional sense of smell in terms of health and well-being is often overlooked until one experiences a loss of smell due to injury or disease. Research demonstrates that individuals are often not self-aware of their smell dysfunction (i.e. they do not spontaneously report smell dysfunction as a symptom), especially if the changes are gradual, as in normal aging. Patients with smell dysfunction experience a marked reduction in quality of life, poor mental health, nutritional health, and brain health as well as increased 5- and 10-year mortality in older adults. This study explores whether or not enabling healthcare providers to offer resources and guidance on coping strategies for smell dysfunction improves health and wellbeing in those who experience it.

Study Overview

• Status: Not yet recruiting
• Conditions: Wellbeing; Olfactory Dysfunction
• Intervention / Treatment: Behavioral: Patient-centered information and education

Detailed Description

The investigators will recruit participants in cycles for in person or remote participation. Each cycle is characterized by an initial assessment, intervention deployment (smell testing), post-intervention evaluation, 1-month and 6-month follow-ups via survey, text or phone to assess post-intervention psychological health and connection to care for smell dysfunction. The research team will assess odor detection, intensity, identification, pleasantness and discrimination. Based on the cut-offs determined prior to the beginning of data collection, the investigators will prospectively assign a participant to the smell dysfunction group or to the normosmia (no smell dysfunction) group. Based on this diagnostic intervention, participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support. At the end of the 1-month and 6-month follow-up periods, the investigators will assess effectiveness of the intervention using pre-post comparisons to determine whether individuals taking a smell test felt improvements in their psychological health and whether they have contacted a provider and/or followed up with a visit.

Sessions may include multiple surveys/instruments depending on the session number. Specifically, emotional ratings and demographic information will be collected by means of either a paper - or computer-based questionnaire. A survey to measure psychological health and quality of life will be given to participants, as well as a questionnaire to measure depression, which is associated with smell dysfunction. Participants will answer questions about how they are feeling and how ready they are to contact a healthcare provider. The specific smell tests that will be given to participants will be either SCENTinel, NIH Toolbox, Arohma, or the B-SIT test. Other Follow-Up Questions include ones regarding access to care, contacting a provider, seeing a provider, and satisfaction with care.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Valentina Parma; Phone Number: +1 (267) 519 - 4680; Email: vparma@monell.org
• Study Contact Backup: Name: Pamela Dalton; Email: dalton@monell.org

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Monell Chemical Senses Center
      • Contact: Ryann Kolb; Phone Number: 2156092024; Email: rkolb@monell.org
      • Contact: Valentina Parma; Email: vparma@monell.org
      • Principal Investigator: Valentina Parma
      • Principal Investigator: Pamela Dalton
      • Principal Investigator: Danielle Reed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Can read and understand English and have access to a reliable internet connection and a smart device or computer for the duration of the experimental sessions, unless they are part of community events in which smart devices are provided

Exclusion Criteria:

- Known intolerance or allergy to any of the odor stimuli used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smell dysfunction detection and educational intervention; Participants will take smell tests and receive educational materials on smell dysfunction.	Behavioral: Patient-centered information and education; Participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support.
No Intervention: Normosmia; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring depression symptoms using the PHQ-9 score	The PHQ-9 is a screening measure of depressive symptoms.	PHQ-9 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring health-related quality of life using the SF-12 survey.	The SF-12 is a screening measure of health-related quality of life.	SF-12 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
Measuring self-reported health perception using a "How do you feel?" 0-100 Visual Analogue Scale (VAS).	"How do you feel?" VAS is a self-reported measure of health perception.	VAS is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
Effectiveness of implementation (to contact a healthcare provider for smell dysfunction within up to 6 months from smell testing).	Participants are asked a Yes or No question about whether they contacted a healthcare provider. The investigators will examine the proportion of participants connecting with a healthcare provider for smell dysfunction.	Evaluated during 1 month and 6 month follow ups

Collaborators and Investigators

• Sponsor: Monell Chemical Senses Center
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Valentina Parma, Monell Chemical Senses Center; Principal Investigator: Pamela Dalton, Monell Chemical Senses Center; Principal Investigator: Danielle Reed, Monell Chemical Senses Center

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: October 22, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Estimated): October 30, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Access to care; Randomized clinical trial; Patient-centered care; Psychological health; Olfactory testing; Smell dysfunction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Olfaction Disorders; Psychological Well-Being; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 856831; R44DC022498 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data
• IPD Sharing Time Frame: When data collection begins, it will be uploaded to Hub4Smell and available for accessing following completion of data collection for every 250 participants. Once access to data on Hub4Smell has been granted, data will be available indefinitely.
• IPD Sharing Access Criteria: Study subject data will be anonymized before data upload to the Hub4Smell database. The anonymization algorithm will be shared with the Hub4Smell Contributors by the Hub4Smell leadership team. Internally, Hub4Smell will associate a persistent surrogate key to identify each record. The study will include metadata attributes to define the data that will be shared with the Hub4Smell database. The Hub4Smell leadership team will trigger loading and sharing procedures of data to the Hub4Smell database. Data will be loaded privately and when marked ready to be shared, will become available to the Hub4Smell Contributors, who will be informed that a new batch of data has been uploaded. Consumers of the data will be required to create an account to download data. Access to source code will be controlled through GitHub user accounts. Access will be approved by the multiple principal investigators (MPIs) and technical teams. Data will be available indefinitely at this time.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No