Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

Rambam Health Care Campus

Status: Unknown

Conditions: Neurodegenerative Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT01291550

0196-09

Details and patient eligibility

About

The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing.

Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).

Enrollment: 300 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients diagnosed with neurodegenerative conditions
• Healthy subjects
• Subjects diagnosed with ADHD

Trial design

300 participants in 3 patient groups

Nerodegenerative diseases

Description:

Patients with parkinsonism and patients with dementia

Controls

ADHD

Description:

Subjects diagnosed with ADHD