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Clinical Trials/NCT02854280
NCT02854280
Completed
Not Applicable

Brain During Effort : Effects of Hypoxia With Respiratory Patients

University Hospital, Grenoble1 site in 1 country33 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
University Hospital, Grenoble
Enrollment
33
Locations
1
Primary Endpoint
Near-infrared spectroscopy (NIRS)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF), the modification of one or the other can affect the neuronal O2 availability.

Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and therefore of the CBF, can create an important dizziness between the demand and the supply of cerebral O2.

It seems that hypoxia can trouble in a significant way the response of central neurons, just as the production of a motor cortex generated motor command.

Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat for brain oxygenation and the motor command, with the consequence a decrease of the exercise performance.

This projects aim to study effects of hypoxia on the brain function for patients suffering from chronic respiratory disease. Neurophysiologic responses of the brain while resting or exercising, including drip and cerebral oxygenation, cortical excitation and motor command resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz in blood.

The study will use a multidisciplinary and supplementary methodological approach : the near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF, neurostimulation procedures and electromyography (EMG) to appreciate the cortical excitability, measure the level of central activation and motor command.

The goals of this study will be :

  • Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of voluntary activation and central fatigue to the effort for the chronic hypoxemic patient compared to healthy control subjects.
  • Analyse disruptions of locomotion parameters and posturographyc, in simple and double task, involving different levels of cerebral task.
  • Analyse acute effects of an improvement of arterial oxygenation for patients suffering from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation, cortical excitability, mechanisms of voluntary activation and central fatigue.
  • Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for patients suffering from obstructive sleep apnea (OSA) with the same parameters.
Registry
clinicaltrials.gov
Start Date
June 2013
End Date
March 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • COPD patients
  • stages GOLD III - IV, FEV1/FVC ratio \< 0,7 and maximum voluntary ventilation (MVV) \< 50% of predicted values
  • BMI \< 30 kg/m²
  • Age between 18 and 80 years
  • Non-smoking or ex-smoker (stop since more than 3 months)
  • Stable condition since more than 3 months
  • PaCO2 \< 45 mmHg resting with ambiant air
  • No OSA diagnostic
  • OSA patients
  • Severe OSA recently dignosed (apnoea-Hypopnoea Index (AHI) \> 30)

Exclusion Criteria

  • OSA and COPD patients
  • Pathologies cardiovascular, neuromuscular, métabolic, renal
  • Alcoholism
  • BMI \> 30 kg/m²
  • Psychiatric disorders or history of behavioural disorders, vision disorders, vestibular disorders, neurologic disease sensitive to disrupt the postural control and the walking, cognitive disorders
  • Instability since less than 3 months
  • Counter argument to the application of an external magnetic field
  • Control subjects
  • Respiratory pathologies, cardiovascular, neuromuscular, metabolic, renal
  • Alcoholism

Outcomes

Primary Outcomes

Near-infrared spectroscopy (NIRS)

Time Frame: Half an hour

Quantities of total desoxyhemoglobin and hemoglobin at muscular and cerebral levels while resting or during effort in response to inhalation of variable fractions of O2 and CO2.

Study Sites (1)

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