Status:
UNKNOWN
Efficacy and Tolerance of Early Launching of Nocturnal Non Invasive
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Association Française contre les Myopathies (AFM), Paris
Conditions:
Myopathy
Muscular Weakness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter randomized controlled open labeled study testing efficacy and tolerance of early launching of night non invasive ventilation in patients with myotonic dystrophy type 1(DM1). The ...
Detailed Description
DM1 is the most frequent genetic myopathy in the adult. Actually there is no curative treatment, and symptomatic cares are essentials. The respiratory impairment is the main cause of morbid-mortality ...
Eligibility Criteria
Inclusion
- Man or woman of age ≥ 18 years
- Preliminary medical examination
- Enlightened and written consent
- Genetically proved Steinert disease
- Presenting at least one of the following 3 criteria
- A hypercapnia: PaCO2 \> 45 mmHg or
- A night-desaturation: SaO2 \< 88 % more than consecutive 5 minutes or
- Apnea syndrome with significant sleep:index of apnea / hypopnea\> a 30 / hour
- And with presence of at least a clinical sign: dyspnoea, orthopnea, headaches, asthenia, diurnal sleepiness, or any other sign suggestive of disturbance of the sleep or of respiratory dysfunction
Exclusion
- Age inferior to 18
- Regime of legal protection
- Pregnancy
- Absolute indication for ventilation: clinical signs (dyspnoea, orthopnea, headaches, asthenia, diurnal sleepiness), AND PaCO2 \> 60 mmHg, AND night-desaturation \< 88 % AND one CV \< 50 % of the theoretical or the PIMAX \< 60 cm H2O
- Acute respiratory failure
- Already ventilated patient
- Patient under oxygen
- Not (beneficiary to a regime of Social Security or legal successor)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01225614
Start Date
October 1 2010
End Date
December 1 2018
Last Update
November 20 2017
Active Locations (1)
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1
Home ventilation unit and intensive care, centre of neuromuscular disease (Garches Mondor Necker Hendaye), Raymond Poincaré hospital Versailles Saint Quentin University.
Garches, France, 92380