Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837637
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-04-19
Brief Title:
The Vietnamese Smell Identification Test in the Diagnosis of Parkinsons Disease
Sponsor:
University Medical Center Ho Chi Minh City UMC
Organization:
University Medical Center Ho Chi Minh City UMC
Study Overview
Official Title:
Validation of the Utility of the Vietnamese Smell Identification Test in Vietnamese Patients With Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to assess the value of the Vietnamese smell identification test VSIT in the diagnosis of Parkinsons 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 Parkinsons disease
The sensitivity specificity positive predictive value and negative predictive value of the BSIT in the diagnosis of Parkinsons 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 Parkinsons 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
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 Parkinsons disease
The sensitivity specificity positive predictive value and negative predictive value of the BSIT in the diagnosis of Parkinsons 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 Parkinsons 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
Detailed Description:
Rational Parkinsons disease is one of the most commonly neurodegenerative disorders neurological outbreaks with an incidence in Vietnam of 80-90100000 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 Parkinsons patients many studies have been conducted with the goal of demonstrating a diminished sense of smell in Parkinsons patients Recent studies have noted that 70-90 of Parkinsons patients have hyposmia Current evidence suggests that Parkinsons 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 Parkinsons disease based on the Parkinsons 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 Parkinsons disease
There are many different tests available on the market to assess olfactory function for Parkinsons 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 Sniffins 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 Parkinsons disease However the popular assessment methods including UPSIT B-SIT and Sniffins 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 Parkinsons disease in Vietnam Therefore investigators conducted this study with the aim to assess the value of the VSIT in the diagnosis of Parkinsons 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 Parkinsons disease
Secondary research objective
To determine the sensitivity specificity positive predictive value and negative predictive value of the BSIT in the diagnosis of Parkinsons disease
To find factors that associated with olfactory identification ability in PD patients
Approach to participants
Patients and controls attending the Parkinson and Movement disorder clinic at UMC will be approached by one of the researchers about the study when the patients come for their regular visit
Research Process
Participants will be assessed cognitive station using MMSE
Information on socio-demographic including age sex education occupation place of residence of both groups and disease-related characteristics will be collected
Participants with PD will be then assessed with the following instruments Movement Disorder Society Unified Parkinsons 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
There are many different tests available on the market to assess olfactory function for Parkinsons 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 Sniffins 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 Parkinsons disease However the popular assessment methods including UPSIT B-SIT and Sniffins 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 Parkinsons disease in Vietnam Therefore investigators conducted this study with the aim to assess the value of the VSIT in the diagnosis of Parkinsons 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 Parkinsons disease
Secondary research objective
To determine the sensitivity specificity positive predictive value and negative predictive value of the BSIT in the diagnosis of Parkinsons disease
To find factors that associated with olfactory identification ability in PD patients
Approach to participants
Patients and controls attending the Parkinson and Movement disorder clinic at UMC will be approached by one of the researchers about the study when the patients come for their regular visit
Research Process
Participants will be assessed cognitive station using MMSE
Information on socio-demographic including age sex education occupation place of residence of both groups and disease-related characteristics will be collected
Participants with PD will be then assessed with the following instruments Movement Disorder Society Unified Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None