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Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01291550
First Posted: February 8, 2011
Last Update Posted: February 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
Rambam Health Care Campus
  Purpose

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).


Condition
Neurodegenerative Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 300
Study Start Date: September 2010
Groups/Cohorts
Nerodegenerative diseases
Patients with parkinsonism and patients with dementia
Controls
ADHD
Subjects diagnosed with ADHD

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Out patient clinic patients diagnosed with neurodegenerative conditions healthy control and subjects diagnosed with ADHD.
Criteria

Inclusion Criteria:

  • Patients diagnosed with neurodegenerative conditions
  • Healthy subjects
  • Subjects diagnosed with ADHD
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291550


Locations
Israel
Cognitive Neurology, Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Judith Aharon-Peretz, M.D    97248543190    memory@rambam.health.gov.il   
Contact: Michal Levavi, MA.RN         
Principal Investigator: Judith Aharon-Peretz, M.D         
Sponsors and Collaborators
Rambam Health Care Campus
Technion, Israel Institute of Technology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Judith aharon-Peretz, Rambam Medica Center
ClinicalTrials.gov Identifier: NCT01291550     History of Changes
Other Study ID Numbers: 0196-09
First Submitted: February 7, 2011
First Posted: February 8, 2011
Last Update Posted: February 8, 2011
Last Verified: September 2010

Keywords provided by Rambam Health Care Campus:
Detecting volatile biomarkers using breath sample

Additional relevant MeSH terms:
Neurodegenerative Diseases
Nervous System Diseases