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

Cognitive Consequences of an Activation of the Cortical Drive to Breath

The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.

Study Overview

• Status: Completed
• Conditions: Healthy; Amyotrophic Lateral Sclerosis; Ondine Syndrome
• Intervention / Treatment: Other: Neuropsychological tests

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 Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients and healthy volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation changes	Modifications of oxygen saturation measured using a saturometer placed on the subject's finger.	3 hours

Collaborators and Investigators

• Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Collaborators: Association Française du Syndrome d'Ondine; Fonds de Recherche en Santé Respiratoire

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2017
• Primary Completion (ACTUAL): July 4, 2019
• Study Completion (ACTUAL): July 4, 2019

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sleep Apnea Syndromes; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sleep Apnea, Central
• Other Study ID Numbers: ADOREPS_2017_9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No