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

Cognitive Consequences of an Activation of the Cortical Drive to Breath

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03095729

Acronym

VENTIPSY

Enrollment

Registered

2017-03-30

Start date

2017-04-26

Completion date

2019-07-04

Last updated

2021-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Healthy, Ondine Syndrome

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.

Interventions

OTHERNeuropsychological tests

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026