NCT02236104

Brief Summary

A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess whether the effects observed persist over time. A better knowledge of this treatment should help to define its position in the respiratory management of neuromuscular patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

September 8, 2014

Last Update Submit

March 23, 2015

Conditions

Mechanical Insufflation-exsufflation Session ( With Cough Assist)

Keywords

neuromuscular disordersmechanical insufflation-exsufflationrespiratory parametersplethysmography opto electronicVital capacity

Outcome Measures

Primary Outcomes (1)

  • maximal inspiratory pressures

    measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.

    2 hours

Study Arms (1)

cough assist session

EXPERIMENTAL

Mechanical insufflation-exsufflation contains 15 cycles durea 2-3 seconds. pressure level fixed +/-30 cm H2O.

Device: Plethysmography opto electronicProcedure: respiratory parameters

Interventions

Plethysmography opto electronicDEVICE
cough assist session
respiratory parametersPROCEDURE
cough assist session

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged more than 18 years
  • Written consents
  • Neuromuscular disorders
  • Hemodynamic stability

You may not qualify if:

  • Pulmonary disorder
  • Acute respiratory failure
  • Cognitive deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincaré

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Frederic LOFASO, MD PHD

    Raymond poincare hospital

    PRINCIPAL INVESTIGATOR

  • Michel Petitjean, MDPHD

    Raymond Poincare hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 10, 2014

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

January 1, 2014

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

FR(1)