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The investigators hypothesized that increasing non intentional leaks could increase work of breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony.
The main objective is to compare ventilatory pattern (work of breathing, flow, pressure) under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10 awakened and asleep obese hypoventilation syndrome (OHS) patients.
Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a random order with an automatically opening valve. Breathing pattern (work of breathing,flow, pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects will be recorded only during awakened state. OHS patients will be recorded both during awake and sleep sates.
Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing according to the different levels of leaks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy and OHS subjects | 10 healthy subjects: 20 to 60 years old 10 patients with Obesity hypoventilation syndrome: 20 to 70 years old treated with nocturnal non invasive ventilation for at least three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non intentional leaks during non invasive ventilation | Other | During NIV sessions (in awake state for both the 10 healthy and the 10 OHS subjects and during sleep only for the OHS subjects), the investigators will create several levels of non intentional leaks in a random order |
| Measure | Description | Time Frame |
|---|---|---|
| Main outcome measure:Work of breathing assessed by measurement of oesophageal pressure according to the levels of non intentional leaks during non invasive ventilation | Oesophageal pressure will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measure: Assessments of the pulse transit time (PTT) and measurement of the oral opening (JAWSENS-NOMICS)according to the levels of non intentional leaks during non invasive ventilation | PTT and oral opening will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) |
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Inclusion Criteria:
Exclusion Criteria:
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10 healthy subjects recruited in professionnal area 10 patients with Obesity hypoventilation syndrome addressed to the sleep laboratory for clinical assessment
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| Name | Affiliation | Role |
|---|---|---|
| Jean Louis Pepin, Pr | Laboratoire EFCR et Sommeil, CHU Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoire EFCR et Sommeil CHU Grenoble | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22523360 | Derived | Contal O, Carnevale C, Borel JC, Sabil A, Tamisier R, Levy P, Janssens JP, Pepin JL. Pulse transit time as a measure of respiratory effort under noninvasive ventilation. Eur Respir J. 2013 Feb;41(2):346-53. doi: 10.1183/09031936.00193911. Epub 2012 Apr 20. |
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