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Completed

NCT Number: NCT03095729

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

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

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Key information

Conditions

Ondine Syndrome Amyotrophic Lateral Sclerosis Apnea Central Nervous System Diseases Dyssomnias Healthy Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neuropsychological tests

Other

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

Primary outcomes

  1. Score at PASAT (Paced Auditory Serial Addition Test)

    Time frame: 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 outcomes

  1. Oxygen saturation changes

    Time frame: 3 hours

    Modifications of oxygen saturation measured using a saturometer placed on the subject's finger.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Association Française du Syndrome d'Ondine
  • Fonds de Recherche en Santé Respiratoire

Registry information

Official study title

Cognitive Consequences of an Activation of the Cortical Drive to Breath

Acronym: VENTIPSY

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2017
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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