Steroid Nasal Irrigation for Flavor Evaluation and Detection Study (SNIFFED)

The Washington University

Status: Completed

Conditions: Olfactory Disorder

Treatments: Behavioral: Smell training

Study type: Interventional

Funder types: Other

Identifiers

NCT02985515

201608163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

Budesonide Nasal Irrigation

No Intervention group

Description:

30-day run-in course of budesonide nasal irrigation. 1-month supply of budesonide capsules, an 8-oz sinus rinse bottle, and a 1-month supply of commercially prepared isotonic salt packets. Participants were instructed to dissolve 2 budesonide capsules (0.5mg per capsule) into the sinus rinse bottle along with the saline mixture and then irrigate both nasal cavities once daily.

Budesonide Nasal Irrigation + Smell Training

Experimental group

Description:

Budesonide nasal irrigation + smell training for 12 weeks

Treatment:

Behavioral: Smell training

Controls

No Intervention group

Description:

Baseline olfaction testing and rs-fMRI