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CompletedNCT00827749PRIODUpdated Jul 22, 2010

Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance

An Early Phase 1 interventional study of respiratory plethysmography by inductance in Swallowing Disorders, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-22.

Sponsored by University Hospital, Grenoble · Early Phase 1, Interventional, and Diagnostic

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Swallowing Disorders

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Keywords

  • swallowing disorders
  • geriatrics
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • Devicerespiratory plethysmography by inductance

    contribution of respiratory plethysmography by inductance and informatic tool

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University Hospital of Grenoble
    Grenoble, Cedex 09, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00827749
Lead sponsor
University Hospital, Grenoble
First posted
Jan 23, 2009
Start date
Nov 2008
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jul 22, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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