Nasal Obstruction and Olfactory Losses
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Nasal Plug.
- Кому может быть актуально
- Состояния в реестре: Nasal Obstruction. Базовые параметры: 18 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
Обзор
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.
Подробное описание
Nasal sinus disease is one of the most common medical conditions in the US, affecting an estimated 13% of adults, or some 30 million people, and responsible for $5.8 billion in health care expenditures annually (National Health Interview Survey 2009, CDC). Nasal obstruction and smell loss are two of the major symptoms of the disease; however, the field currently lacks a clear, objective understanding of the mechanisms causing these symptoms, which thwarts effective treatment. For example, patients' complaints of nasal obstruction correlate poorly or inconsistently with objective measurements of actual physical obstruction. Without validated clinical tools, the current treatment of these symptoms relies primarily on the patient's subjective feedback and the doctor's personal training and experience, which can lead to inconsistent and unsatisfactory outcomes.
Through a series of preliminary studies, the investigators demonstrated that the symptom of nasal obstruction may be caused not by obstruction per se but by poor sensing of airflow during breathing or sensing may be worsened by impaired trigeminal function. However, which trigeminal sensory regions and what nasal airflow anomalies are most critical in disrupting the sensing of airflow are still unknown. In Aim 2, the investigators will investigate the efficacy of a novel patent-pending "nasal aid" to improve patients' symptoms by modulating nasal airflow and trigeminal sensory feedback and to improve future treatment outcomes based on what the investigators have learned and will continue to learn about the airflow trigeminal perception mechanisms.
The outcomes from this research may potentially validate several novel clinical tools to better identify factors that most affect patients' obstructive symptoms and to relieve symptoms by modulating nasal airflow patterns. The ultimate goal is to assist patients and clinicians in planning effective, well-informed, personalized treatment strategies, potentially saving millions of healthcare dollars annually while improving patient satisfaction.
Вмешательства
- Другое Nasal Plug
Please see the arm description for details.
Первичные конечные точки
- Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire [Срок оценки: 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.]
- Change in Visual Analog Scale (VAS) of nasal obstruction [Срок оценки: 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.]
- Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q) [Срок оценки: 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.]
Вторичные конечные точки (3)
- Change in Sino-nasal Outcome Test (SNOT-22) [Срок оценки: 1-baseline (done on the first day of testing)and 2- 8 weeks after surgery]
- Change in nasal resistance [Срок оценки: 1-baseline (done on the first day of testing) and 2- 8 weeks after surgery]
- Change in rhinomanometry [Срок оценки: 1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery]
Критерии участия
Критерии включения
- Smell Loss complaints
- Nasal Obstruction
Критерии исключения
- Congenital olfactory losses
- Nasal polyps, blocking the olfactory cleft
- Significant atrophy
- Cystic fibrosis
- Wegeners or any other connective tissue disorder
- Head trauma
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000 — Columbus
Публикации
- Formanek VL, Spector BM, Zappitelli G, Wu Z, Zhao K. Designing novel "Smell-Aids" to improve olfactory function in post COVID-19 era. BMC Med. 2025 Mar 24;23(1):169. doi: 10.1186/s12916-025-03999-y. PMID 40128836
Идентификаторы
NCT: NCT05920330 · 2015H0262