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

Healthy Clinical Trial

— VENTIPSY  

Official title:

Cognitive Consequences of an Activation of the Cortical Drive to Breath

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095729
• Other study ID #: ADOREPS_2017_9
• Status: Completed
• Start date: April 26, 2017
• Est. completion date: July 4, 2019

Study information

• Verified date: July 2021
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 4, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Healthy
• Motor Neuron Disease
• Ondine Syndrome
• Sleep Apnea, Central

Intervention

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

Locations

Country	Name	City	State
France	INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière	Paris

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oxygen saturation changes	Modifications of oxygen saturation measured using a saturometer placed on the subject's finger.	3 hours