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Sponsored by: |
University Hospital, Grenoble |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00827749 |
The purpose of this study is to evaluate the efficiency of a novel non-invasive method for swallowing disorders detection in geriatrics.
Condition | Intervention | Phase |
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Swallowing Disorders |
Device: respiratory plethysmography by inductance |
Phase 0 |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD) |
Estimated Enrollment: | 30 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Interest: swallowing disorders exist at any age. More common among the elderly, their prevalence is estimated at between 15 and 50% of more than 60 years. Recognized today as a health problem of particular concern within this population, their pathological consequences are multiple and severe: inhalation pneumonia, often a complication of "the wrong track", was recognized in the USA in 1989, as 5th cause of death among patients aged 65, and the 3rd leading cause of death of patients over 85 years. Malnutrition facilitates infections by depression of the immune system and promotes the development of bedsores. The swallowing disorders resulting in an increase in the prevalence of dehydration, social isolation, but also an increase in mortality. Faced with such consequences, it is therefore necessary to have a reliable, non-invasive approach adapted to the fragility of the elderly to detect these disorders in order to promote preventive strategies and / or curative justified.
Originality: This work, which is part of a clinical approach uses a new method of swallowing study, described in A. Moreau-Gaudry's Medicine thesis :
"Assets of the respiratory inductance plethysmography to the study of swallowing in geriatrics." The originality of this lies in the combination of Respiratory Plethysmography by inductance (RPI) to the informatic tool. The PRI allows continuous recording, thanks to a vest connected to a laptop, the patient's breathing rate. Readily available at the patient's bedside, it is non-invasive and perfectly suited to the fragility of the study population. The tool, by its automatic guarantees objectivity and reproducibility of the analysis of deglutitions from respiratory signal provided by the RPI.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alain Franco, M.D, PhD | KGuerrero@chu-grenoble.fr | |
Contact: Alexandre Moreau-Gaudry, MD, PhD | AMoreau-Gaudry@chu-grenoble.fr |
France, Cedex 09 | |
University Hospital of Grenoble | Recruiting |
Grenoble, Cedex 09, France | |
Contact: Alain Franco, M.D, PhD | |
Principal Investigator: Alain Franco, MD.,PhD | |
Sub-Investigator: Marc Hommel, MD; PhD | |
Sub-Investigator: Gilbert Ferretti, MD | |
Sub-Investigator: Ivan Bricault, MD, PhD | |
Sub-Investigator: Odile Magnillat, MD | |
Sub-Investigator: Moufida Benbadis, MD | |
Sub-Investigator: Alexandre Moreau-Gaudry, MD, PhD | |
Sub-Investigator: Christian RIGHINI, MD, PhD |
Responsible Party: | University Hospital of Grenoble ( Dr Alexandre Moreau-Gaudry ) |
Study ID Numbers: | DCIC 05 22 |
Study First Received: | January 22, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00827749 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
swallowing disorders geriatrics |
Deglutition Disorders Otorhinolaryngologic Diseases Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Esophageal Diseases Pharyngeal Diseases |
Deglutition Disorders Pathologic Processes Otorhinolaryngologic Diseases Digestive System Diseases |
Disease Gastrointestinal Diseases Esophageal Diseases Pharyngeal Diseases |