Effect of Olfactory Training on Olfactory Dysfunction Patients in Hong Kong Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Olfactory identification score changes after olfactory training after 3 months
研究概览
简要总结
- Causes of olfactory dysfunction can be classified into conductive and sensorineural causes.
- Conductive causes are mainly due to structural nasal problem, which can be treated by nasal surgery
- Sensorineural causes included post-infection, post-head injury, post Head and Neck irradiation and other central nervous system diseases.
- Olfactory Training is well established treatment for sensorineural olfactory dysfunction in foreign countries.
- Olfactory Training by neurological chemosensory stimulation using aromatic substances delivered via electronic portable aromatic rehabilitation (EPAR) diffuser was proved to be effective treatment in COVID-19 related olfactory dysfunction in recent Hong Kong study.
- However, there is a lack of local study on the effect of Olfactory Training in other non-COVID-19 sensorineural causes of olfactory dysfunction in Hong Kong population.
详细描述
Design Prospective double-blinded randomized control trial.
Study Period 1/7/2022 - 30/6/2024 for case recruitment.
Suitable patient will be recruited. Informed consent will be signed. Objective smell assessment will be done using the University of Pennsylvania Smell Identification Test (UPSIT) and Butanol Threshold Test (BTT). Subjective quality of life score will be obtained by Sino-Nasal Outcome Test (SNOT-22). Subjective smell and taste assessment will be assessed by Visual Analogue Scale (VAS). Patient will be randomized into treatment group and control group using computer generated list by an independent nursing staff. Doctors and the patients will be blinded during the study.
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 (Investigator)
盲法说明
Randomly assigned by computer into treatment group and control group
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Olfactory dysfunction > 6 months and < 5 years
排除标准
- •History of significant head injury (fracture, ICH)
- •History of brain surgery
- •History of nasal surgery
- •Active nasal disease
- •Active neurological disease
- •Poor premorbid status/ non-communicable patients
- •Mentally incompetent patients
- •<18 years' old
- •Pregnancy
- •Hypersensitivity to the aromatic substance.
结局指标
主要结局
Olfactory identification score changes after olfactory training after 3 months
时间窗: 3 months after starting smell training
Parameter: Olfactory identification using Smell Identification Test (UPSIT)
Quality of life changes after olfactory training after 3 months
时间窗: 3 months after starting smell training
Parameter: Subjective quality of life score using Sino-Nasal Outcome Test (SNOT-22)
Taste and smell changes after olfactory training after 3 months
时间窗: 3 months after starting smell training
Parameter: Subjective smell and taste assessment using Visual Analogue Scale (VAS)
Olfactory threshold changes after olfactory training after 3 months
时间窗: 3 months after starting smell training
Parameter: Olfactory threshold using Butanol Threshold Test (BTT)
次要结局
未报告次要终点
研究者
Fergus Wong Kai Chuen
Associate Consultant
Pamela Youde Nethersole Eastern Hospital