Clinical trial NCT04613531: The Sensitivity and Specificity of Canine Detection of Parkinson's Disease
Official title: The Sensitivity and Specificity of Sniffer Dogs for Diagnosis of Parkinson's Disease: Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: University of South China
name: Mingji Hospital
First posted: 2020-11-03
Enrollment: 1198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients and other subjects in clinics

Brief summary: People sometimes report that their relatives who have been diagnosed with Parkinson's disease (PD) have a unique smell. A previous study has demonstrated that PD patients do have smell that is different from that of healthy people. Sniffer dogs have long been used to identify criminals, and recently been used to identify subject with cancer. The investigators hypothesized that sniffer dogs may be able to identify PD patients.

Detailed description: Parkinson's Disease is a neurodegeneration disorder that affects the life of millions of people worldwide. There are multiple drugs available now that can modify the process of the disease. Making a timely and correct diagnosis of PD is still a great challenge in many cases even for specialists. Correct diagnosis is fundamental to the appropriate administration of medicines. To help clinicians to quickly and correctly make a diagnosis, the investigators aim to use sniffer dogs to identify PD patients from clearly non-PD subjects. After more than one-year training of the dogs, the investigators found that it is feasible to use dogs to identify PD patients from non-PD subjects. Now the investigators are trying to estimate the sensitivity and specificity of sniffer dogs in identifying PD patients from non-PD subjects.

In this multicenter study, the clinicians and their assistants will collect samples and send to the study center. One researcher alone will put seven plastic bags containing matched samples (one PD sample and six non-PD samples) on a table and take notes, then relabel them with random numbers and take notes again, and keep them in a confidential place till the study is completed. Another researcher will take over the relabeled samples and put them into different tanks and take notes. Thus, both the experimenter who helps to place the samples into tanks and the dog handler will not know the nature of the samples. Test results will be compared with the notes of the blind-setter after all the experiments have been performed. The sensitivity and specificity of identification will be calculated. The study aims to test the hypothesis that the diagnostic sensitivity of sniffer dogs in identifying PD patients from non-PD subjects is over 90%.

Eligibility criteria: Inclusion Criteria:

* Clinically established PD patients
* Clearly non-PD subjects will be recruited as controls

Exclusion Criteria:

* subjects with tremor or decrease of olfactory power or with rapid eye movement sleep behavior, obvious constipation, and depression.
* subjects who are taking antipsychotics.
* subjects with incomplete data.

Primary outcomes:
measure: The specificity and sensitivity of the identification of PD patients from non-PD by at least 2 out of 3 sniffer dogs
timeFrame: Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks
Secondary outcomes:
measure: Assess the accuracy of identification by sniffer dogs for PD patients with disease duration over five years and for those with disease duration within five years of diagnosis.
timeFrame: Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: XiangYa Hospital
state: Hunan
Study officials:
affiliation: Xiang-Ya Hospital, Central South University
name: Chang-Qing Gao, MD,PhD
role: STUDY_DIRECTOR
References: