Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19

Официальное название

L'entraînement Olfactif Comme Traitement de la Dysfonction Olfactive Post COVID-19

Обзор

Olfactory dysfunction is a defining symptom of COVID-19 infection. Studies have demonstrated improved olfaction in patients with post infectious olfactory dysfunction after an olfactory training (OT). The aim of this study is to assess the clinical outcomes of olfactory training (12 weeks) therapy in the treatment of persistent olfactory dysfunctions after COVID-19. Specially, we aim to compare the effectiveness of two different olfactory training (different odors). A group will train themselves with 4 scents (rose, orange, clove and eucalyptus) and another group with 4 different scents (cheese, coffee, strawberries and lemon). Olfaction sensory evaluation will be performed by using different olfaction tests (Sniffin' Sticks and UPSIT) and complete questionnaires to assess olfactory perception and particularly parosmia and phantosmia.

Подробное описание

Patients who meet the criteria, who have agreed to participate in this research project and sign the consent form will be placed in one of the following two groups:

● Experimental group (olfactory training)

1. Initial meeting: Each participant will be asked for a session of approximately 1:30 h which will take place in a ventilated room in the laboratory of Dr. Johannes Frasnelli at UQTR. During the hour preceding this evaluation, subjects will be asked not to smoke, eat or drink anything other than water and not to wear perfume. A research assistant will be responsible for completing the various tests. During this meeting, the following tests will be done:

* Data collection (case report form): medical and socio-demographic questionnaire that will be used for data analysis. * A nasal obstruction criterion scale - NOSE * A subjective questionnaire on the impact of OD on quality of life - sQOD-NS * Chemosensory Dysfunction Home Test - TMSC * The UPSIT 40 test * The Sniffin' Sticks test * Test to assess the manifestation of parosmia and phantosmia * Teaching on the olfactory rehabilitation kit and explanation of the training protocol. 2. Treatment (12 weeks): Following the initial meeting, patients can begin training:

■ Participants will bring their training kit with them following the olfactory evaluation. 3. Final meeting: After 12 weeks of treatment, an appointment will be scheduled with the participant. The olfactory evaluation will be done as described in the initial meeting. During the hour preceding this evaluation, subjects will be asked not to smoke, eat or drink anything other than water and not to wear perfume. A research assistant will be responsible for administering the various tests. During this meeting, the following tests will be done:

* A subjective questionnaire on the impact of OD on quality of life - sQOD-NS * Chemosensory Dysfunction Home Test - TMSC * The UPSIT 40 test * The Sniffin' Sticks test * Test to assess the manifestation of parosmia and phantosmia

Вмешательства

• Другое Smell training
  For 12 weeks, morning and evening, smell four different odors or four odorless substances for a total of five minutes per session.

Первичные конечные точки

• Changes from baseline in olfactory score on the University of Pennsylvania Identification Test (UPSIT) [ Time Frame: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention) [Срок оценки: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)]
• Changes from baseline in olfactory score on the Sniffin's Sticks test [Срок оценки: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)]
• n-house test for chemosensory dysfunction (TMSC) [Срок оценки: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)]
• Parosmia and phantosmia assessment test [Срок оценки: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)]
• The abridged version of the Questionnaire of Olfactory Disorders - Negative Statements (sQOD-NS) [Срок оценки: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)]

Вторичные конечные точки (1)

• Nasal Obstruction Symptom Evaluation (NOSE) [Срок оценки: Measurement will be taken at time zero (pre-intervention)]

Критерии участия

Критерии включения

• Patient diagnosed positive for COVID-19 with persistent olfactory dysfunction
• Willing and able to provide written informed consent
• Understand and read the French language
• Have an internet connection and a working email address

Критерии исключения

• Anosmia and hyposmia pre-covid-19
• Be known chronic rhinosinusitis with or without nasal polyposis
• Have received radiotherapy or chemotherapy for Head and Neck Tumors
• Have a diagnosis of Alzheimer's, Parkinson's, multiple sclerosis or any other neurodegenerative disease 5. Have a brain tumor or ENT diagnosis 6. History of naso-sinus surgery; 7. History of traumatic brain injury

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

Канада · 1 центр

• Université du Québec à Trois-Rivières — Trois-Rivières

Идентификаторы

NCT: NCT05384561 · OTTODC192022JFUQTR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗