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CompletedNCT01090674Updated Feb 24, 2014

Relationship Between Respiratory Functional Tests and Image Thoracic Techniques in Patients With Neuromuscular Diseases

An observational study in Amyotrophic Lateral Sclerosis, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2014-02-24.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Sex
All
01

Study summary

It is very important monitoring respiratory muscle function in patients with amyotrophic lateral sclerosis (ALS). We have at our disposal Respiratory Functional Tests (forced vital capacity (FVC), maximal mouth-inspiratory force (MIF), maximal mouth-expiratory force (MEF), Cough Peak expiratory flow (cPEF), maximal voluntary ventilation (MVV), arterial blood gases and nocturnal pulsioxymetry) and Thoracic Image Techniques (inspiratory/expiratory Thorax x-ray and x-ray scope). But all this explorations present some technique limitations. They are two new methods to explore diaphragmatic function: SNIF test and Diaphragm magnetic resonance imaging (dMRI). SNIF test is simple and easy to be done and it can avoid some problems that have the other respiratory functional test in this kind of patients. dMRI seems to correlate with respiratory functional test and it can be useful monitoring diaphragmatic mobility. The objective of our study is to compare and to correlate SNIF test and dMRI with x-ray techniques and respiratory functional tests that measure diaphragmatic force and function. First of all we will study 10 healthy people with a forced spirometry, MIF, MEF and dMRI, trying to obtain diaphragmatic mobility reference values with dMRI. Lately, we will study patients with ALS. In the first place, we will perform a transversal study with 30 patients. We will do a forced spirometry, MIF, MEF, MVV, cPEF, SNIF, arterial blood gases and nocturnal pulsioxymetry, forced Inspiratory and expiratory Thorax x-ray, diaphragmatic x-ray scope and dMRI. Secondly, we will perform a prospective study, where we will analyze these variables evolution at 3 and 6 months. We hope we can apply the two new techniques in the future because we think they are simpler, more accurate and more objective to evaluate diaphragmatic mobility.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Diaphragmatic force
  • mobility
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 5 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with amyotrophic lateral sclerosis.

Inclusion criteria

  • Amyotrophic lateral sclerosis patients.
  • Clinically stable, at least for one month.

Exclusion criteria

Exclusion Criteria:

  • Claustrophobic patients.
  • Patients using continuous non-invasive ventilation treatment.
  • Incapacity to tolerate supine decubitus.
  • Incapacity to execute respiratory functional tests.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)

Groups and cohorts

  • 1

    Patients with amyotrophic lateral sclerosis.

    Other: No intervention

Interventions

  • OtherNo intervention

    We perform in all patients respiratory functional tests, thoracic x-ray, SNIF test and diaphragmatic magnetic resonance imaging.

06

What researchers measure

Primary outcomes

  1. Different measures of diaphragmatic mobility, force and function.

    To compare and correlate all different image techniques that evaluate diaphragmatic mobility with all different respiratory functional variables that measure diaphragmatic (and muscular in general) force and function.

    Time frame: One year

Secondary outcomes

  1. Diaphragmatic MRI usefulness

    * To evaluate dMRI usefulness in monitoring diaphragmatic mobility. * To evaluate if we can establish a value of diaphragm mobility (in mm) observed with dMRI to suggest the initiation of non invasive ventilation treatment. * To evaluate if dMRI can predict ALS prognosis.

    Time frame: One year

07

Study locations

1 site
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01090674
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Sponsor
First posted
Mar 22, 2010
Start date
Jun 2007
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Feb 24, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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