Treatment of Postviral Olfactory Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Subjective health
研究概览
简要总结
A decreased sense of smell (hyposmia) is often caused by viral infections, such as COVID-19. Today, the only recommended treatment for hyposmia is olfactory training, a time consuming method with limitations in terms of both compliance and effect. The aim of this study is therefore to evaluate, as well as optimize, a new treatment method for olfactory loss.
Hyposmic participants will be recruited and randomized into two different treatment conditions. One group will do regular olfactory training and the other will do passive olfactory training with scented nose plugs. The training will be conducted in the home of the individual monday through friday for two consecutive months. Subjective and objectvie measures of olfactory problems will be assessed before and after treatment, as well as subjective measures related to quality of live and genereal wellbeing.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 years old
- •Physically and cognitively capable of participating in the study
- •Having appropriate olfactory screening test scores (hyposmic)
排除标准
- •Individuals with other diagnoses that could affect the study results
结局指标
主要结局
Subjective health
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on subjective health compared to regular olfactory training? For this outcome, we will use the Self-Rated Health 5 measure and SF-36.
Objective olfactory function
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on objective olfactory function compared to regular olfactory training? For this outcome, we will use the standardized Sniffin' Sticks test to assess olfactory function.
Subjective degree of suffering from olfactory impairment
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on subjective degree of suffering from olfactory impairment compared to regular olfactory training? For this outcome, we will use the Questionnaire of Olfactory Disorders - Negative Statements.
Subjective parosmia
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on subjective parosmia compared to regular olfactory training? For this outcome, we will use the Landis parosmia questionnaire.
Subjective depressive symptoms
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on depressive symptoms compared to regular olfactory training? For this outcome, we will use the Beck Depression Inventory (BDI).
Subjective general wellbeing
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on depressive symptoms compared to regular olfactory training? For this outcome, we will use the General Well Being Schedule.
Subjective symptoms and social/emotional consequences
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on subjective symptoms and social/emotional consequences compared to regular olfactory training? For this outcome, we will use the Sino-Nasal Outcome Test (SNOT).
Subjective olfactory function
时间窗: 2 months
Does the use of scented nose plugs increase the effect of olfactory training on subjective olfactory function compared to regular olfactory training? For this outcome, we will use the Self-Reported Mini Olfactory Questionnaire.
Compliance
时间窗: 2 months
Does the use of scented nose plugs increase the compliance of olfactory training compared to regular olfactory training? For this outcome, we will use questions asking the participants about their experience during the olfactory training, specifically targeting their compliance, such as how often they actually completed the olfactory training and how often they forgot to.
次要结局
未报告次要终点
研究者
Johan Lundström
Professor
Karolinska Institutet