Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

NCT ID: NCT01291550

Last Updated: 2011-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Neurodegenerative Diseases

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Nerodegenerative diseases

Patients with parkinsonism and patients with dementia

No interventions assigned to this group

Controls

No interventions assigned to this group

ADHD

Subjects diagnosed with ADHD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with neurodegenerative conditions
* Healthy subjects
* Subjects diagnosed with ADHD
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technion, Israel Institute of Technology

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Rambam Medica Center

Locations

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Cognitive Neurology, Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Judith Aharon-Peretz, M.D

Role: primary

97248543190

Michal Levavi, MA.RN

Role: backup

References

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Tisch U, Schlesinger I, Ionescu R, Nassar M, Axelrod N, Robertman D, Tessler Y, Azar F, Marmur A, Aharon-Peretz J, Haick H. Detection of Alzheimer's and Parkinson's disease from exhaled breath using nanomaterial-based sensors. Nanomedicine (Lond). 2013 Jan;8(1):43-56. doi: 10.2217/nnm.12.105. Epub 2012 Oct 15.

Reference Type DERIVED
PMID: 23067372 (View on PubMed)

Other Identifiers

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0196-09

Identifier Type: -

Identifier Source: org_study_id

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