Impact of Smell Testing on Health Outcomes

NCT ID: NCT07222891

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-11-30

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.

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.

Conditions

Olfactory Dysfunction; Wellbeing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Smell dysfunction detection and educational intervention

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

Group Type: EXPERIMENTAL

Patient-centered information and education

Intervention Type: 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.

Normosmia

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Monell Chemical Senses Center

OTHER

Sponsor Role: lead

Responsible Party

Valentina Parma

Assistant Member and Senior Director of Multisector Engagements

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valentina Parma

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Pamela Dalton

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Danielle Reed

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Locations

Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Valentina Parma

Role: CONTACT

vparma@monell.org

+1 (267) 519 - 4680

Pamela Dalton

Role: CONTACT

dalton@monell.org

Facility Contacts

Ryann Kolb

Role: primary

rkolb@monell.org

2156092024

Valentina Parma

Role: backup

vparma@monell.org

Other Identifiers

R44DC022498

Identifier Type: NIH

Identifier Source: secondary_id

View Link

856831

Identifier Type: -

Identifier Source: org_study_id