Cognitive Consequences of an Activation of the Cortical Drive to Breath (VENTIPSY)
Study Details
Study Description
Brief Summary
The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Cognitive capacities are measured on healthy subject submitted to inspiratory threshold loading, patients treated by chronic mechanical ventilation due to suffering Ondine syndrome or amyotrophic lateral sclerosis. The spontaneous breathing is compared to NIV breathing or inspiratory threshold loading.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy 40 healthy subjects, during quiet breathing and under an inspiratory load (inspiratory threshold loading) |
Other: Neuropsychological tests
A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)
|
| Ondine syndrome 12 patients presenting with central hypoventilation syndrome or Ondine's curse syndrome, during spontaneous breathing and with Non Invasive Ventilation |
Other: Neuropsychological tests
A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)
|
| Amyotrophic Lateral Sclerosis 30 patients presenting with Amyotrophic Lateral Sclerosis during spontaneous breathing and with Non Invasive Ventilation |
Other: Neuropsychological tests
A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)
|
Outcome Measures
Primary Outcome Measures
- Score at PASAT (Paced Auditory Serial Addition Test) [3 hours]
Performances will be assessed by counting the number of good and wrong answers, and comparing it in two conditions : spontaneous breathing (SB) versus inspiratory resistive loading for healthy subjects, and SB versus non invasive ventilation for patients.
Secondary Outcome Measures
- Oxygen saturation changes [3 hours]
Modifications of oxygen saturation measured using a saturometer placed on the subject's finger.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults and non-vulnerable adults
-
Fluent in French
Exclusion Criteria:
For patients:
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Total ventilatory dependency
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Coexistence of an other respiratory disease
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Alcohol and /or psychotropic consumption during the last 24 hours
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One or more episodes of acute respiratory failure during the past 6 months
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Serious cognitive deficiency or presence of fronto temporal dementia
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End-stage disease
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No affiliation to social security
For healthy volunteers:
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Existing respiratory disease
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Alcohol and /or psychotropes consumption during the last 24 hours
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Tobacco smoking more than 2 pack-years
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Sleep deprivation
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Serious cognitive deficiency
-
No affiliation to social security
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière | Paris | France | 75013 |
Sponsors and Collaborators
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Association Française du Syndrome d'Ondine
- Fonds de Recherche en Santé Respiratoire
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADOREPS_2017_9