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NCT01291550 Clinical Trial

Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

Neurodegenerative Diseases Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01291550
Other study ID # 0196-09
Secondary ID
Status Recruiting
Phase N/A
First received February 7, 2011
Last updated February 7, 2011
Start date September 2010

Study information
Verified date September 2010
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients diagnosed with neurodegenerative conditions

- Healthy subjects

- Subjects diagnosed with ADHD

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Cognitive Neurology, Rambam Medical Center Haifa

Sponsors (2)
Lead Sponsor Collaborator
Rambam Health Care Campus Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

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