Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance (PRIOD)

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. Identifier: NCT00827749
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : July 22, 2010
Information provided by:
University Hospital, Grenoble

Brief Summary:
The purpose of this study is to evaluate the efficiency of a novel non-invasive method for swallowing disorders detection in geriatrics.

Condition or disease Intervention/treatment Phase
Swallowing Disorders Device: respiratory plethysmography by inductance Early Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD)
Study Start Date : November 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: respiratory plethysmography by inductance
    contribution of respiratory plethysmography by inductance and informatic tool

Primary Outcome Measures :
  1. Can we detect with a non-invasive, infra clinical, objective and non-traumatic tool, a patient's deglutitions from an automatic analysis of a recording of his breathing rate? [ Time Frame: 2.5 hours ]

Secondary Outcome Measures :
  1. Can we detect with a non-invasive, infra clinical, objective and non-traumatic tool pathological deglutitions from an automatic analysis of a recording of his breathing rate? [ Time Frame: 2.5 hours ]
  2. Can we have a test to classify patients into two groups - those without swallowing disorders and those with swallowing disorders - from an analysis of quantitative parameters relating to the analysis of the breathing rate? [ Time Frame: 2.5 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients major, consenting, cooperating.
  • Person registered with the French Social Security or benefiting from an equivalent health insurance system

Exclusion Criteria:

  • Patients do not qualify for inclusion pre-cited,
  • Patients in a period of exclusion for other studies,
  • Patients with behavioural problems that prevent them joining a clinical trial requiring prolonged collaboration (state of rest with minimal mobilization of the patient, a necessary condition to acquire a breathing rate of quality, and therefore an analysis of quality),
  • Patient suffering from a nosocomial infection,
  • Patient the acute stage of a condition involving the life of the latter,
  • Patient insufficient breathing, oxygen, with respiratory failure poorly supported despite oxygen,
  • Patient in respiratory failure decompensated
  • Patient at the end of life

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 identifier (NCT number): NCT00827749

University Hospital of Grenoble
Grenoble, Cedex 09, France
Sponsors and Collaborators
University Hospital, Grenoble

Responsible Party: Dr Alexandre Moreau-Gaudry, University Hospital of Grenoble Identifier: NCT00827749     History of Changes
Other Study ID Numbers: DCIC 05 22
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010

Keywords provided by University Hospital, Grenoble:
swallowing disorders

Additional relevant MeSH terms:
Deglutition Disorders
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases