Cognitive Consequences of an Activation of the Cortical Drive to Breath (VENTIPSY)
VENTIPSY
1 other identifier
observational
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 30, 2017
CompletedStudy Start
First participant enrolled
April 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2019
CompletedJuly 9, 2021
July 1, 2021
2.2 years
March 9, 2017
July 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Score at PASAT (Paced Auditory Serial Addition Test)
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.
3 hours
Secondary Outcomes (1)
Oxygen saturation changes
3 hours
Study Arms (3)
Healthy
40 healthy subjects, during quiet breathing and under an inspiratory load (inspiratory threshold loading)
Ondine syndrome
12 patients presenting with central hypoventilation syndrome or Ondine's curse syndrome, during spontaneous breathing and with Non Invasive Ventilation
Amyotrophic Lateral Sclerosis
30 patients presenting with Amyotrophic Lateral Sclerosis during spontaneous breathing and with Non Invasive Ventilation
Interventions
A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)
Eligibility Criteria
Patients and healthy volunteers
You may qualify if:
- Adults and non-vulnerable adults
- Fluent in French
You may not qualify if:
- For patients:
- Total ventilatory dependency
- Coexistence of an other respiratory disease
- Alcohol and /or psychotropic consumption during the last 24 hours
- One or more episodes of acute respiratory failure during the past 6 months
- Serious cognitive deficiency or presence of fronto temporal dementia
- End-stage disease
- No affiliation to social security
- For healthy volunteers:
- Existing respiratory disease
- Alcohol and /or psychotropes consumption during the last 24 hours
- Tobacco smoking more than 2 pack-years
- Sleep deprivation
- Serious cognitive deficiency
- No affiliation to social security
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2017
First Posted
March 30, 2017
Study Start
April 26, 2017
Primary Completion
July 4, 2019
Study Completion
July 4, 2019
Last Updated
July 9, 2021
Record last verified: 2021-07