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临床试验/NCT05837637
NCT05837637招募中不适用

Validation of the Utility of the Vietnamese Smell Identification Test in Vietnamese Patients With Parkinson's Disease

University Medical Center Ho Chi Minh City (UMC)1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2023年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
218
试验地点
1
主要终点
The VSIT score of both groups

研究概览

简要总结

The goal of this observational study is to assess the value of the Vietnamese smell identification test (VSIT) in the diagnosis of Parkinson's disease, and compare it with the commonly used test in the world, Brisk smell identification test (BSIT)

The main questions it aims to answer are:

  • The sensitivity, specificity, positive predictive value, and negative predictive value of the VSIT in the diagnosis of Parkinson's disease?
  • The sensitivity, specificity, positive predictive value, and negative predictive value of the BSIT in the diagnosis of Parkinson's disease?
  • Factors that associated with olfactory identification ability in PD patients?

Process:

  • Participants will be assessed cognitive station using MMSE
  • Information on socio-demographic including age, gender, education, occupation, place of residence of both groups, and disease-related characteristics will be collected.
  • Participants with Parkinson disease will be then assessed with the following instruments: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Hoehn & Yarh scale, and Beck Depression Inventory
  • The case and control groups will be assessed by the Vietnamese Smell Identification Test and Brisk Smell Identification Test

详细描述

Rational Parkinson's disease is one of the most commonly neurodegenerative disorders neurological outbreaks with an incidence in Vietnam of 80-90/100,000 people. It comprises of motor and non-motor symptoms (NMS). Motor symptoms include tremor, bradykinesia, rigidity, gait difficulties, postural instability and falls. Non-motor symptoms are diverse including a wide range of symptoms involving almost systems of the body. A number of nonmotor symptoms may precede motor symptoms by several years, including olfactory dysfunction, constipation, REM sleep behavior disorder, and depression. Since1975, after Ansari and Johnson reported impaired olfactory function in Parkinson's patients, many studies have been conducted with the goal of demonstrating a diminished sense of smell in Parkinson's patients. Recent studies have noted that 70-90% of Parkinson's patients have hyposmia. Current evidence suggests that Parkinson's patients may experience disturbances in various aspects of olfactory function including odor detection, odor discrimination, and odor perception. However, some studies indicated that odor recognition function was more often affected than odor discrimination function. Nowadays, hyposmia is one of the supportive criteria in the diagnosis of Parkinson's disease based on the Parkinson's disease diagnostic criteria of the Movement Disorders Association. Besides, hyposmia when combined with other signs on DAT-Scan and on transcranial Doppler ultrasound help increase the accuracy in diagnosing Parkinson's disease.

There are many different tests available on the market to assess olfactory function for Parkinson's patients, of which the most commonly used tests are UPSIT (University of Pennsylvania Smell Identification Test), B-SIT (Brief Smell Identification test). Identification Test) and Sniffin's Sticks. UPSIT is an odor identification test, developed in 1984 with 40 different odorants. UPSIT has been shown to be highly reliable and valuable in the assessment of odor disorders 19. However, evaluating UPSIT took a long time, so a simpler version of UPSIT with 12 different flavors suitable for many cultures was created called B-SIT. These 12 scents were selected from surveys conducted in several countries in North America, South America, Europe and Asia. In Asia, surveys were conducted in Japan and China. Many studies have shown that B-SIT has good sensitivity and specificity in the diagnosis of Parkinson's disease. However, the popular assessment methods including UPSIT, B-SIT and Sniffin's Sticks were all developed in other parts of the world, so there are many odors in these tests that are not familiar to Vietnamese people. The 12-item Vietnamese smell identification test (VSIT) has been developed to evaluate olfactory function for the Vietnamese population. The VSIT demonstrated good validity and reliability. To date, there have been no studies evaluating the effectiveness of odor identification tests in diagnosing Parkinson's disease in Vietnam. Therefore, investigators conducted this study with the aim to assess the value of the VSIT in the diagnosis of Parkinson's disease, and compare it with the commonly used test in the world, B-SIT.

Primary research objective:

• To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the VSIT in the diagnosis of Parkinson's disease?

Secondary research objective:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years and older
  • MMSE score > 24
  • Clinical diagnosis of Parkinson's disease (for patient group)

排除标准

  • History of trauma to the head, history of nasal bone fracture, and history of nasal cosmetic surgery
  • Brain neoplasms
  • History of stroke, epilepsy
  • Secondary Parkinson's and Parkinson's Plus
  • Other neurodegenerative diseases, such as Alzheimer's
  • Mental disorders, such as schizophrenia, depression
  • Upper respiratory tract infections in the 2 weeks
  • Pregnancy
  • Exposure to medications relating to olfactory reduction, for instance, some particular antibiotics, antiepileptics, antithyroid or benzodiazepines
  • Having reported COVID-19 compatible smell symptomatology

结局指标

主要结局

The VSIT score of both groups

时间窗: From May 2023 to May 2025

The VSIT score of both groups will be calculated after testing

次要结局

  • The BSIT score of both groups(From May 2023 to May 2025)

研究者

发起方
University Medical Center Ho Chi Minh City (UMC)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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