Informations générales (source: ClinicalTrials.gov)
Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS) (NIV-OHS)
Interventional
N/A
Tyco Healthcare Group (Voir sur ClinicalTrials)
juin 2006
juin 2008
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble - 38043 - Grenoble - Cedex 9 - France | Jean-Louis Pepin, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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