Nasal Obstruction and Olfactory Losses
ConditionNasal Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOhio State University
About this trial
About 13% of US adults, some 30 million people, suffer from nasal sinus disease. Although nasal obstruction and smell loss are two of the major symptoms of the disease that are crucial to disease management, currently there is a lack of clinical tools to effectively evaluate the mechanisms contributing to these symptoms. The proposed study aims to develop novel clinical tools to better evaluate and relieve patients' nasal obstructive symptoms and to enable patients and clinicians to make more informed, personalized decisions regarding treatment strategy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Smell Loss complaints
Nasal Obstruction
Disqualifiers
Congenital olfactory losses
Nasal polyps, blocking the olfactory cleft
Significant atrophy
Cystic fibrosis
Trial design
Design model
Single group
Treatments tested in this trial
Nasal Plug
Other interventionPlease see the arm description for details.
Treatment groups
330 Participants
are divided into 1 treatment groupGroup A: Single ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.
Time frame
3 time points: 1-baseline, 2-after the applications of nasal aid (done on the first day of testing), and 3- 8 weeks after surgery.2
Change in Visual Analog Scale (VAS) of nasal obstruction
A visual analog scale of nasal obstruction (VAS), with ratings from 0 to 10 (0 = completely clear; 10 = completely obstructed).
Time frame
3 time points:1-baseline, 2-after the applications of nasal aid (done on the first day of testing) and 3-8 weeks after surgery.3
Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q)
A validated ENS-specific symptom questionnaire.
Time frame
3 time points:1-baseline, 2-after the applications of nasal aid (done on the first day of testing) and 3-8 weeks after surgery.Secondary outcomes
1
Change in Sino-nasal Outcome Test (SNOT-22)
A validated questionnaire documenting general nasal sinus symptoms.
Time frame
1-baseline (done on the first day of testing)and 2- 8 weeks after surgery2
Change in nasal resistance
Anterior rhinomanometry will be used to measure airflow and pressures during normal breathing.
Time frame
1-baseline (done on the first day of testing) and 2- 8 weeks after surgery3
Change in rhinomanometry
The narrowest area of the nasal airway measured by an acoustic rhinometry.
Time frame
1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgerySponsors and contacts
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Source ClinicalTrials.gov