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OBJECTIVES/GOALS: The primary aim is to evaluate the efficacy of a Mandibular Advancement Device (MAD) vs conservative treatment for adults with non-apneic snoring, as measured by the sleeping partner. The secondary aim is to evaluate the effectiveness of treatment of snoring on the sleeping partner’s sleep quality. METHODS/STUDY POPULATION: We plan to enroll 60 pairs of primary snorers and their sleeping partners in our randomized clinical trial. Snorers will be randomized to either 4 weeks of conservative therapy, consisting of nightly Mometasone nasal rinse, breathe-rite strips, mouth taping, and lateral positional therapy, or 4 weeks of Mandibular Advancement Device therapy (MAD). 30 pairs of snorers and their partners will be in each arm. At follow up the primary outcome measure, the Clinical Global Impression of Improvement Scale (CGI-I), will be assessed by the sleeping partner to evaluate the response to snoring treatment. RESULTS/ANTICIPATED RESULTS: To date, there is no study reporting the rate of response in participants using MAD in Primary Snoring. Due to lack of preliminary data and effect size, we hypothesize that the rate of the responders in the MAD group will be 20% higher than the rate of responders in the active control group based on literature studies and preliminary results. A responder will be classified as someone whose sleeping partner rates on the CGI-I scale that the snoring was much improved or very much improved. MAD has been shown previously to be an effective therapy at treating sleep apnea and reducing snoring, and we anticipate it will continue to be so for patients who do not have sleep apnea. DISCUSSION/SIGNIFICANCE: Snoring is a nearly ubiquitous problem that prevents restful sleep for spouses of snorers, which is known to have detrimental health effects. Yet it does not have scientifically proven treatments. Our study will evaluate these treatments in an effort to improve the health of the sleeping partners.
ABSTRACT IMPACT: By developing and validating a simple and cost-effective at-home screening tool for loss of smell, we can efficiently detect infection with COVID-19, neuropsychiatric disease such as Alzheimer’s, and post-operative smell loss. OBJECTIVES/GOALS: To develop and validate a feasible and cost-effective screening tool for olfactory dysfunction (OD) using common household items. METHODS/STUDY POPULATION: The study has two phases. In the Development phase, 120 participants with self-reported smell changes will complete a survey with a list of 45 household items to smell. Item reduction to develop the NASAL Short Smell Test will occur by measuring content validity, factor analysis, and internal consistency. In the Validation phase, 200 participants with self-reported smell changes will take the NASAL Short Smell Test at baseline and again at three weeks. In both phases, the validated University of Pennsylvania Smell Identification Test (UPSIT) will be used as the gold standard. Measures of performance as well as test-retest reliability and sensitivity to change will be measured. RESULTS/ANTICIPATED RESULTS: We anticipate that the majority of participants will have at least half of the items in their household and will report ability to smell for each. Measures of sensitivity, specificity, likelihood ratios, and UPSIT score correlations will allow us to evaluate performance of each item. Item reduction will allow us to create the NASAL Short Smell Test, in which a handful of common items will be used to create a screening tool for smell loss. The Validation phase will allow us to measure discriminative performance of this tool as well as test-retest reliability and sensitivity to change, which we expect to be at least comparable to the validated UPSIT. DISCUSSION/SIGNIFICANCE OF FINDINGS: Current tools for diagnosis of OD are costly, time-consuming, and often require a clinician to evaluate. The validation of the simple at-home NASAL Short Smell Test to screen for OD will allow us to detect infection with COVID-19, neuropsychiatric disease, or post-operative smell loss quickly and efficiently.
ABSTRACT IMPACT: Olfactory dysfunction is a defining symptom of COVID-19 infection. As the number of total, confirmed COVID-19 cases approaches 7 million in the United States, it is estimated that there will be up to 500,000 new cases of chronically diminished smell. We offer a promising treatment. OBJECTIVES/GOALS: The primary aim is to explore the main effects and interaction of bimodal visual-olfactory training and patient-preferred scents on olfactory training in patients with post-COVID-19 hyposmia or anosmia. METHODS/STUDY POPULATION: The study will utilize a 2x2 factorial design. The two effects we will explore are unimodal versus bimodal training and conventional versus patient-preferred odors. All 4 arms will undergo 12 weeks of olfactory training. Participants will be assessed pre and post-intervention. Measurements of olfactory function include the objective smell identification test and subjective measures including the Clinical Global Impression Scale and Olfactory Dysfunction Outcomes Rating. Individuals eligible for the study include men and women between 18 and 70 years of age with olfactory dysfunction of at least 3 months duration initially diagnosed within 2 weeks of a COVID-19 infection. Of note, we will enroll nationally. RESULTS/ANTICIPATED RESULTS: We anticipate that the bimodal, patient-preferred scents training group will have the greatest improvement in smell scores, number of responders, and patient-reported sense of smell and health-related quality of life due to an additive interaction between the bimodal visual-olfactory and patient-preferred interventions. DISCUSSION/SIGNIFICANCE OF FINDINGS: The pathophysiology of COVID-19 olfactory dysfunction is mediated through damage to the peripheral and central olfactory pathways. This suggests that interventions most likely to be efficacious target both pathways, as olfactory training does.