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Идёт набор NCT05539560

The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction

Без фазы С лечением COVID-19

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: Olfactory training with essential oils, Olfactory training with fragrance-free oils.
Кому может быть актуально
Состояния в реестре: COVID-19. Базовые параметры: от 18 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
Дания
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

The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction - A Randomized Placebo-controlled Clinical Trial

Обзор

Aim: The aim is to investigate the effect of olfactory training with essential oils versus olfactory training with placebo-oils in patients with COVID-19 induced olfactory dysfunction Study design: The study is a placebo-controlled randomized clinical trial with an intervention group and a control group. The intervention group receive four essential oils with scents of orange, lavender, clove, and peppermint. Patients in the control group receive a fragrance kit, consisting of the same containers, but with fragrance-free oils added. Both groups are instructed to smell each of the four oils for 30 seconds in the morning and evening, over a three-month intervention period. Patients are given a diary in which to record their olfactory training. The nurse or medical student instructing the patients in the training and performing the smell and taste tests is blinded. Study population: Patients referred to the Unit for Sense of Taste and Smell in the Department of Otorhinolaryngology Head \& Neck and Audiology at Rigshospitalet. Inclusion criteria: * Impaired sense of taste and smell following COVID-19 \> 3 months * Hyposmia (16.25-30.5) or anosmia (\<16) assessed by Sniffin' Sticks Olfactory Test for Threshold, Discrimination and Identification (TDI) performed in the Unit for Sense of Taste and Smell with or without parosmia based on medical history * \> 18 years of age Exclusion criteria: * Cause of hyposmia, anosmia or parosmia other than COVID-19 * Does not read or speak Danish * Lack of compliance to perform daily olfactory training Procedures: \- TDI-test: To assess patients' sense of smell, the TDI-test with Sniffin' Sticks is used, which is a validated tool with normative data. Questionnaires: \- 'Taste and Smell Tool for Evaluation' is used to investigate quality of life related to impaired sense of taste and smell.

Вмешательства

  • Другое Olfactory training with essential oils
    Olfactory training twice daily with essential oils from Urtegaarden Aps with scents of orange, lavender, clove and peppermint. The olfactory training is performed every morning and evening, by smelling each of the oils for 30 seconds.
  • Другое Olfactory training with fragrance-free oils
    Olfactory training twice daily with fragrance-free oils from Urtegaarden Aps in the same four containers as the intervention group. The olfactory training is performed every morning and evening, by smelling each of the oils for 30 seconds.

Первичные конечные точки

  • Change in Extended Sniffin' Sticks Test score [Срок оценки: 3 months follow-up]
Вторичные конечные точки (1)
  • Change in Quality of Life [Срок оценки: 3 months follow-up]

Критерии участия

Критерии включения

  • Olfactory dysfunction caused by COVID-19
  • Hyposmia (16.25-30.5) or anosmia (<16) with or without parosmia assessed by TDI test with Sniffin Sticks performed in the Unit for Sense of Taste and Smell
  • > 18 years of age

Критерии исключения

  • Cause of hyposmia, anosmia or parosmia other than COVID-19
  • Does not read or speak Danish
  • Lack of compliance to perform daily olfactory training

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen Universit — Copenhagen

Публикации

  • Mogensen DG, Aanaes K, Andersen IB, Jarden M, Backer V. Effect of Olfactory Training in COVID-19 Related Olfactory Dysfunction-A Placebo-Controlled Trial. Laryngoscope. 2025 Dec;135(12):4849-4857. doi: 10.1002/lary.32275. Epub 2025 May 15. PMID 40371997

Идентификаторы

NCT: NCT05539560 · 2022-ENT-1-olfactory

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗