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

Completed

• Conditions: Ondine Syndrome; Amyotrophic Lateral Sclerosis; Healthy
• Interventions: Other: Neuropsychological tests

• Registration Number: NCT03095729
• Lead Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

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.

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-30
• Study Start: 2017-04-26
• Primary Completion: 2019-07-04
• Study Completion: 2019-07-04
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ondine syndrome	Neuropsychological tests	12 patients presenting with central hypoventilation syndrome or Ondine's curse syndrome, during spontaneous breathing and with Non Invasive Ventilation
Amyotrophic Lateral Sclerosis	Neuropsychological tests	30 patients presenting with Amyotrophic Lateral Sclerosis during spontaneous breathing and with Non Invasive Ventilation
Healthy	Neuropsychological tests	40 healthy subjects, during quiet breathing and under an inspiratory load (inspiratory threshold loading)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Oxygen saturation changes	3 hours	Modifications of oxygen saturation measured using a saturometer placed on the subject's finger.

Trial Locations

Locations (1)

INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière; 🇫🇷 Paris, France