Impact of Smell Testing on Health Outcomes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7+
SponsorMonell Chemical Senses Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Patient-centered information and education
BehavioralParticipants 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Smell dysfunction detection and educational interventionExperimental treatment 1 intervention
Group B: NormosmiaNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Measuring depression symptoms using the PHQ-9 score
The PHQ-9 is a screening measure of depressive symptoms.
Time frame
PHQ-9 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.Secondary outcomes
1
Measuring health-related quality of life using the SF-12 survey.
The SF-12 is a screening measure of health-related quality of life.
Time frame
SF-12 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.2
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.
Time frame
VAS is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.3
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.
Time frame
Evaluated during 1 month and 6 month follow upsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Monell Chemical Senses Center
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov