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

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ClinicalTrials.gov Identifier: NCT03095729
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
Association Française du Syndrome d'Ondine
Fonds de Recherche en Santé Respiratoire
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ondine Syndrome Healthy Amyotrophic Lateral Sclerosis 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.

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Study Type : Observational
Estimated Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cognitive Consequences of an Activation of the Cortical Drive to Breath
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


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)




Primary Outcome Measures :
  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 Outcome Measures :
  1. Oxygen saturation changes [ Time Frame: 3 hours ]
    Modifications of oxygen saturation measured using a saturometer placed on the subject's finger.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients and healthy volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095729


Contacts
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Contact: Jessica Taytard 0142178196 ext 0033 jessica.taytard@aphp.fr

Locations
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France
INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Thomas Similowski, MD, PhD    01 42 16 77 97 ext 0033    thomas.similowski@aphp.fr   
Contact: Sophie Lavault, PhD    01 42 17 81 96 ext 0033    bureau@adoreps.fr   
Sponsors and Collaborators
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
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Responsible Party: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
ClinicalTrials.gov Identifier: NCT03095729    
Other Study ID Numbers: ADOREPS_2017_9
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Central
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders