Clinical trial NCT02985515: Steroid Nasal Irrigation for Flavor Evaluation and Detection Study
Official title: Steroid Nasal Irrigation for Flavor Evaluation and Detection (SNIFFED) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olfactory Disorder
Keywords: Anosmia
Hyposmia
Intranasal Steroid Irrigation
Olfactory Neuroplasticity
Olfactory training
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective cohort, pre- and post-intervention study
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to examine the efficacy of a 12-week smell training intervention for participants with olfactory dysfunction following an infection of the upper respiratory tract.

Detailed description: Olfactory dysfunction affects up to fifteen percent of the general population and can cause significant psychosocial distress including decreased appetite, reduced self-hygiene, and mood disturbances.

This study aims to study the efficacy of smell training for patients with olfactory dysfunction following a viral upper respiratory tract infection. Eligible participants will complete a 30-day course of budesonide nasal saline irrigation. Participants who do not show improvement in their olfaction based on composite smell and taste tests will be eligible to receive a baseline resting-state fMRI (rs-fMRI) and complete a 12-week smell training intervention program. Smell training involves participants smelling 4 odors (phenyl ethyl alcohol, eucalyptus, lemon, and eugenol) twice a day for 12 weeks. Following completion of smell training, participants will undergo repeat smell and taste tests as well as rs-fMRI to ascertain the efficacy of smell training.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70
* Anosmia or hyposmia (UPSIT \<34 (male), UPSIT \<34 (female); Sniffin' Sticks threshold below 5.5)

Exclusion Criteria:

* Inability to understand English
* Current smoker or history of smoking within the past 6 months
* Current nasal polyps
* Exposure to head and or/neck radiation
* Exposure to chemotherapy

Primary outcomes:
measure: Pre- and Post-intervention Difference in Functional Connectivity Before and After Smell Training.
timeFrame: 12 weeks
Secondary outcomes:
measure: Pre- and Post-intervention Difference in Smell Testing Before and After Budesonide Treatment
timeFrame: 30 days
measure: Subjective Response to Smell Training Intervention
timeFrame: 12 weeks
measure: Comparison of Olfactory Network in Healthy Controls to Study Participants
timeFrame: 1 week
measure: Pre- and Post-intervention Difference in Smell Testing Before and After Smell Training
timeFrame: 12 weeks
measure: Pre and Post Difference in QOD-NS After Smell Training
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay F Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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