The Sensitivity and Specificity of Canine Detection of Parkinson's Disease

NCT ID: NCT04613531

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-01-22

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%.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with PD

patients with clinically diagnosed Parkinson's disease

No interventions assigned to this group

Participants without PD

participants clinically diagnosed without Parkinsons' Disease

No interventions assigned to this group

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South China

OTHER

Sponsor Role: collaborator

Mingji Hospital

OTHER

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Qing Gao

Director, Center for studies in laboratory animals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang-Qing Gao, MD,PhD

Role: STUDY_DIRECTOR

Xiang-Ya Hospital, Central South University

Locations

XiangYa Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

Xiang Ya 0005

Identifier Type: -

Identifier Source: org_study_id