Cognitive Consequences of an Activation of the Cortical Drive to Breath (VENTIPSY)

NCT ID: NCT03095729

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2019-07-04

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.

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.

Conditions

Ondine Syndrome; Healthy; Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy

40 healthy subjects, during quiet breathing and under an inspiratory load (inspiratory threshold loading)

Neuropsychological tests

Intervention Type: OTHER

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

Neuropsychological tests

Intervention Type: OTHER

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

Neuropsychological tests

Intervention Type: OTHER

A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)

Interventions

Neuropsychological tests

A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults and non-vulnerable adults
• Fluent in French

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Association Française du Syndrome d'Ondine

UNKNOWN

Sponsor Role: collaborator

Fonds de Recherche en Santé Respiratoire

UNKNOWN

Sponsor Role: collaborator

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

ADOREPS_2017_9

Identifier Type: -

Identifier Source: org_study_id