NCT00827749

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 22, 2010

Status Verified

July 1, 2010

Enrollment Period

1.6 years

First QC Date

January 22, 2009

Last Update Submit

July 21, 2010

Conditions

Swallowing Disorders

Keywords

swallowing disordersgeriatrics

Outcome Measures

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?

    2.5 hours

Secondary Outcomes (2)

  • 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?

    2.5 hours

  • 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?

    2.5 hours

Interventions

respiratory plethysmography by inductanceDEVICE

contribution of respiratory plethysmography by inductance and informatic tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, Cedex 09, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

November 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 22, 2010

Record last verified: 2010-07

Locations

FR(1)