Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization (NCT00603096) | Clinical Trial Compass
UnknownNot Applicable
Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization
France45 participantsStarted 2006-06
Plain-language summary
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
Who can participate
Age range20 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patient male or female, aged 20 to 75 years
* Patient with a OHS in stable condition, with a BMI\> 32 kg/m2 and a PaCO2\> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation
* Patient affiliated to a social security insurance
* Having given its written informed consent to participate to the study
Exclusion Criteria:
* Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%
* Patients suffering from heart failure with periodic breathing
* Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities
* Unbalanced Psychiatric Diseases
* Patients with a respiratory decompensation the month preceding the study
* Patients not autonomous in the use of the NIV
* Pacemaker patients, constituting a contraindication to magnetic stimulation
* Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code
* Patients with long term by steroids or other anti-inflammatory drugs