L'entraînement Olfactif Comme Traitement de la Dysfonction Olfactive Post COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Parosmia and phantosmia assessment test
研究概览
简要总结
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.
详细描述
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)
- 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.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Have a brain tumor or ENT diagnosis
- •History of naso-sinus surgery;
- •History of traumatic brain injury
研究组 & 干预措施
Chemosensory training group 2
For 12 weeks, morning and evening, smell four odors namely coffee aroma, cheese aroma, strawberries, and limon, for a total of five minutes per session.
干预措施: Smell training (Other)
Chemosensory training group 1
For 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, Orange, and eugenol, for a total of five minutes per session.
干预措施: Smell training (Other)
结局指标
主要结局
Parosmia and phantosmia assessment test
时间窗: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
This test has a first part with four questions that aim to assess the presence of parosmia or phastosmia. Patients who have reported parosmia or phantosmia will be asked to complete a second part with six questions focusing on the quality of their olfactory distortion.
n-house test for chemosensory dysfunction (TMSC)
时间窗: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
The TMSC is a 55-item questionnaire evaluating the three chemical senses: olfaction, taste and the trigeminal sense. First, questions with a 10-point visual analog scale make a subjective self-assessment of each of the three senses. Multiple-choice questions establish the precise characteristics of the dysfunctions of each of the senses if they are present. Secondly, a psychophysical test is administered remotely using substances typical of North American cuisines. Substances are first sniffed (peanut butter, jam, vinegar, coffee) then tasted (peanut butter, jam, salt water (1 tsp/250mL), sugar water (3 tsp/250mL)). The perceived intensity of each of the substances is reported each time on a visual analogue scale of 10 points.
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)
时间窗: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
The UPSIT includes 4 odor-impregnated booklets that contain 10 forced-choice multiple choice questions each for participants to scratch-and-sniff to identify various odors and is a commercially available test. Normosmia is defined as ≥34 for males and ≥35 for females, and a change of 4 points or more from baseline indicates a clinically meaningful result.
Changes from baseline in olfactory score on the Sniffin's Sticks test
时间窗: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.
The abridged version of the Questionnaire of Olfactory Disorders - Negative Statements (sQOD-NS)
时间窗: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
The sQOD-NS is a validated questionnaire that measures the quality of life specific to olfactory functions. The questionnaire measures 7 items with a 4-point Likert scale.
次要结局
- Nasal Obstruction Symptom Evaluation (NOSE)(Measurement will be taken at time zero (pre-intervention))