Impact of Smell Testing on Health Outcomes

NCT07222891 | Not Yet Recruiting Phase 2

• 2 other identifiers: 856831R44DC022498
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Olfactory Dysfunction; Wellbeing

Keywords

Olfactory testing; Smell dysfunction; Psychological health; Randomized clinical trial; Patient-centered care; Access to care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Measuring health-related quality of life using the SF-12 survey.

  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).

  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).

  Evaluated during 1 month and 6 month follow ups

Study Arms (2)

Smell dysfunction detection and educational intervention

EXPERIMENTAL

Participants will take smell tests and receive educational materials on smell dysfunction.

Behavioral: Patient-centered information and education

Normosmia

NO INTERVENTION

No intervention

Interventions

Patient-centered information and education BEHAVIORAL

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.

Smell dysfunction detection and educational intervention

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Monell Chemical Senses Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Olfaction Disorders; Psychological Well-Being

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Valentina Parma

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

• Pamela Dalton

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

• Danielle Reed

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Parma

CONTACT

+1 (267) 519 - 4680; vparma@monell.org

Pamela Dalton

CONTACT

dalton@monell.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Member and Senior Director of Multisector Engagements

Model Details: Olfactory data will be collected with six standardized smell tests in the in-person cohort and four standardized smell tests in the remote cohort. The research team will assess odor detection, intensity, identification, pleasantness and discrimination. Based on the cut-off scores determined before the beginning of data collection, the investigators will assign a participant to the smell dysfunction group or to the normosmia (non-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.

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 30, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)