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Набор скоро начнётся NCT06837051

The Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With CRS

Без фазы С лечением Olfactory Dysfunction Chronic Rhinosinusitis

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: Conventional olfactory training device, Modified olfactory training device, Budesonide irrigation.
Кому может быть актуально
Состояния в реестре: Olfactory Dysfunction, Chronic Rhinosinusitis. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Официальное название

Protocol for a Randomized Controlled Trial Evaluating the Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With Chronic Rhinosinusitis

Обзор

The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are: Is it possible that the device can treat postoperative olfactory dysfunction in patients with chronic sinusitis? Compared to the conventional device, how efficient is the modified olfactory training device for treating postoperative olfactory dysfunction in patients with chronic sinusitis?

Подробное описание

Endoscopic sinus surgery is an effective treatment for treating olfactory dysfunction related to chronic rhinosinusitis. However, recent studies have shown that most patients experience a return of olfactory function to preoperative levels within months to a year after surgery. Clinically, olfactory training after endoscopic sinus surgery has been proven beneficial for the olfactory recovery.

The improved olfactory training device, based on a nasal bidirectional drug delivery system, can increase the deposition rate in the olfactory fissure region and improve the efficiency of olfactory training.

In this study, the investigators planned to recruit 213 patients and divided them into three groups for control group and olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on changes in cognitive function and the comparison of the outcomes of the three groups.

Вмешательства

  • Устройство Conventional olfactory training device
    Four odorants are used: phenyl ethyl alcohol (PEA): rose, menthol: mint, citronellal: lemon, and eugenol: cloves. Training patients will receive four glass vials. Each contains one odorant (5 mL, soaked in cotton pads to prevent spilling) and is labeled with the name of the odorant. Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.
  • Устройство Modified olfactory training device
    The modified olfactory training device is based on the nasal bidirectional drug delivery system. The device uses breathing pressure to create positive pressure, significantly increasing the deposition rate of odors in the olfactory cleft area. Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.
  • Препарат Budesonide irrigation
    Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.

Первичные конечные точки

  • The Sniffin's Sticks test [Срок оценки: Baseline,Month 3,Month 6,Month 12]
Вторичные конечные точки (5)
  • Olfactory cleft CT score [Срок оценки: Baseline,Month 3,Month 6,Month 12]
  • Olfactory cleft endoscopy scale (OCES) [Срок оценки: Baseline,Month 3,Month 6,Month 12]
  • OB volume measurement [Срок оценки: Baseline,Month 3,Month 6,Month 12]
  • Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS) [Срок оценки: Baseline,Month 3,Month 6,Month 12]
  • Olfactory-Visual Analogue Scale (VAS) [Срок оценки: Baseline,Month 3,Month 6,Month 12]

Критерии участия

Критерии включения

  • A diagnosis of CRSsNP based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS20).
  • The duration after endoscopic sinus surgery is 3months.
  • Olfactory dysfunction confirmed with the Sniffin's Sticks psychophysical test (TDI score≦30.5) .
  • Willingness to participate in this study and sign the informed consent form (ICF).

Критерии исключения

  • Patients with olfactory impairment due to traumatic, congenital, toxic/drug-induced causes, tumors, or post-upper respiratory infections.
  • Lund-Mackay olfactory cleft score > 0.
  • Patients with severe comorbidities, such as malignant tumors.
  • Current or planned pregnancy prior to the end of study.
  • Patients who are unable to complete the study or are unable to comply with the requirements of the study (such as inability to tolerate olfactory function testing and treatment, memory or behavioral abnormalities, depression, smoking, heavy alcohol use, previous delinquent behavior)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Beijing — Пекин

Публикации

  • Li Y, Li Y, Zhang Y, Wu D. Protocol for a randomised controlled trial evaluating the effect of modified olfactory training on postoperative olfactory dysfunction in patients with CRS. BMJ Open. 2025 Aug 16;15(8):e101870. doi: 10.1136/bmjopen-2025-101870. PMID 40819876

Идентификаторы

NCT: NCT06837051 · 9059104

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗