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CompletedNCT03445832PREMDENUpdated Aug 17, 2018

Pulmonary Function and Neuromuscular Disease

An observational study in Neuromuscular Diseases, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

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Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
21
Ages
6 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 84 studies in Neuromuscular Diseases with a site in France — 14 open to participants now, 17 under way, 2 of them phase 3. Neuromuscular Diseases · France.

Enrollment
32nd of 36
21 · median 73
Started
2018
with 4 others
Observational
36 of 84
8 open now
Registered
40th of 84
by date

Among the 84 studies in Neuromuscular Diseases with a site in France, this one is the 32nd largest by enrollment of the 36 observational ones that give a count, is one of 5 that started in 2018, is one of 36 observational ones, and was the 40th registered.

Neuromuscular Diseases

361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.

Browse Neuromuscular Diseases studies →

Open to participants now

14 of the 84 studies in Neuromuscular Diseases with a site in France are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 70 Neuromuscular Diseases studies recruiting now, 39 (56%) set no upper age limit and 23 (33%) stop at 75 or younger; 36 take children under 18; 16 take healthy volunteers.

This study: 6 Years to 17 Years · all sexes · no healthy volunteers.

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02

Study summary

This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.

03

Conditions studied

  • Neuromuscular Diseases
04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children suffering from neuromuscular diseases and followed-up in Besançon University Hospital between 2006/01/01 and the beginning of this study

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Inclusion criteria

  • Neuromuscular disease
  • Followed-up in Besançon University Hospital
  • With at least 2 Pulmonary Function Tests previously performed

Exclusion criteria

Exclusion Criteria:

  • Mental deficiency
  • Facial expressions disorders
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
21 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. FVC (Forced Vital Capacity)

    Percentage of decrease of FVC sitting or lying down

    Time frame: Year 12

07

Study locations

1 site
  • CHU de Besançon
    Besançon, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Feb 2018, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2018
First posted
Feb 26, 2018
StartActual
Jan 8, 2018
Primary completionActual
Feb 10, 2018
CompletionActual
Feb 10, 2018
Last update
Aug 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03445832
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jan 8, 2018
Primary completion
Feb 10, 2018
Completion
Feb 10, 2018
Last update
Aug 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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